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Home › Patent cliff › Exclusivity

Regulatory exclusivity cliff: 852 FDA exclusivities ending through 2031

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

852 FDA regulatory exclusivities on brand-name drugs (NDAs) end between October 11, 2026 and December 31, 2031, per the FDA Orange Book. Exclusivity is separate from patents: it runs from approval (five years for a new chemical entity, seven for an orphan drug, three for a new indication, six months added for pediatric studies) and blocks the FDA from approving certain competing applications until it ends, whatever the patents say. It is often an earlier date than the last patent. Orange Book data files dated September 11, 2026.

An exclusivity ending is not a generic launch. Patents, settlements and the time a generic needs for approval decide when a competitor actually reaches the market. This page lists the FDA's exclusivity dates only. Not investment advice.

By type: orphan drug (ODE): 286; new chemical entity (NCE): 164; pediatric (PED): 110; new indication (I): 82; new patient population (NPP): 59; new product (NP): 57; miscellaneous (M): 49; qualified infectious disease product (GAIN) (GAIN): 21; new strength (NS): 13; new dosing schedule (D): 10; NDF (NDF): 1.

2026 · 59 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Oct 11, 2026Braftovi (encorafenib)Array Biopharma IncI-928 (new indication)210496
Oct 11, 2026Mektovi (binimetinib)Array Biopharma IncI-928 (new indication)210498
Oct 17, 2026Combogesic Iv (acetaminophen; ibuprofen sodium)Hikma Pharmaceuticals Usa IncNP (new product)215320
Oct 17, 2026Qlosi (pilocarpine hydrochloride)Orasis Pharmaceuticals LtdNP (new product)217836
Oct 17, 2026Xphozah (tenapanor hydrochloride)Ardelyx IncNP (new product)213931
Oct 18, 2026Orenitram (treprostinil diolamine)United Therapeutics CorpODE-272 (orphan drug)203496
Oct 18, 2026Savaysa (edoxaban tosylate)Daiichi Sankyo IncM-14 (miscellaneous)206316
Oct 20, 2026Cabtreo (adapalene; benzoyl peroxide; clindamycin phosphate)Bausch Health Us LlcNP (new product)216632
Oct 20, 2026Epidiolex (cannabidiol)Jazz Pharmaceuticals Research Uk LtdM-270 (miscellaneous)210365
Oct 20, 2026Rozlytrek (entrectinib)Genentech IncNPP (new patient population)212725
Oct 20, 2026Rozlytrek (entrectinib)Genentech IncNP (new product)218550
Oct 20, 2026Voxzogo (vosoritide)Biomarin Pharmaceutical IncNPP (new patient population)214938
Oct 21, 2026Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-275 (orphan drug)212273
Oct 21, 2026Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE* (orphan drug)212273
Oct 22, 2026Corlanor (ivabradine)Amgen IncPED (pediatric)209964
Oct 23, 2026Zejula (niraparib tosylate)Glaxosmithkline LlcODE-277 (orphan drug)208447
Oct 24, 2026Tibsovo (ivosidenib)Servier Pharmaceuticals LlcI-924 (new indication)211192
Oct 29, 2026Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)207925
Oct 29, 2026Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpNCE (new chemical entity)215358
Oct 30, 2026Mavyret (glecaprevir; pibrentasvir)Abbvie IncPED (pediatric)209394
Nov 1, 2026Voquezna (vonoprazan fumarate)Phathom Pharmaceuticals IncNP (new product)215151
Nov 3, 2026Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)207925
Nov 8, 2026Farxiga (dapagliflozin)Astrazeneca AbPED (pediatric)202293
Nov 8, 2026Zepbound (autoinjector) (tirzepatide)Eli Lilly And CoNP (new product)217806
Nov 9, 2026Exparel (bupivacaine)Pacira Pharmaceuticals IncI-929 (new indication)022496
Nov 10, 2026Rexulti (brexpiprazole)Otsuka Pharmaceutical Co LtdPED (pediatric)205422
Nov 13, 2026Breo Ellipta (fluticasone furoate; vilanterol trifenatate)Glaxo Group Ltd England Dba GlaxosmithklPED (pediatric)204275
Nov 14, 2026Brukinsa (zanubrutinib)Beone Medicines Usa IncODE-276 (orphan drug)213217
Nov 14, 2026Brukinsa (zanubrutinib)Beone Medicines Usa IncODE* (orphan drug)218785
Nov 17, 2026Xtandi (enzalutamide)Astellas Pharma Us IncI-926 (new indication)203415
Nov 17, 2026Xtandi (enzalutamide)Astellas Pharma Us IncI-926 (new indication)213674
Nov 19, 2026Voxzogo (vosoritide)Biomarin Pharmaceutical IncNCE (new chemical entity)214938
Nov 20, 2026Givlaari (givosiran sodium)Alnylam Pharmaceuticals IncODE-273 (orphan drug)212194
Nov 21, 2026Calquence (acalabrutinib)Astrazeneca Uk LtdODE-274 (orphan drug)210259
Nov 23, 2026Livtencity (maribavir)Takeda Pharmaceuticals Usa IncNCE (new chemical entity)215596
Nov 24, 2026Jakafi (ruxolitinib phosphate)Incyte CorpPED (pediatric)202192
Nov 25, 2026Oxbryta (voxelotor)Global Blood Therapeutics IncODE-281 (orphan drug)213137
Nov 25, 2026Oxbryta (voxelotor)Global Blood Therapeutics IncODE* (orphan drug)216157
Nov 29, 2026Cytalux (pafolacianine sodium)On Target Laboratories IncNCE (new chemical entity)214907
Dec 5, 2026Phyrago (dasatinib)Handa Therapeutics LlcM-307 (miscellaneous)216099
Dec 8, 2026Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncNPP (new patient population)207500
Dec 8, 2026Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncNPP (new patient population)207501
Dec 12, 2026Vyondys 53 (golodirsen)Sarepta Therapeutics IncODE-280 (orphan drug)211970
Dec 13, 2026Idose Tr (travoprost)Glaukos CorpNP (new product)218010
Dec 13, 2026Iwilfin (eflornithine hydrochloride)Uswm LlcNP (new product)215500
Dec 14, 2026Welireg (belzutifan)Merck Sharp And Dohme Corp A Sub Of MercI-931 (new indication)215383
Dec 15, 2026Triumeq (abacavir sulfate; dolutegravir sodium; lamivudine)Viiv Healthcare CoPED (pediatric)205551
Dec 15, 2026Triumeq Pd (abacavir sulfate; dolutegravir sodium; lamivudine)Viiv Healthcare CoPED (pediatric)215413
Dec 15, 2026Zoryve (roflumilast)Arcutis Biotherapeutics IncNP (new product)217242
Dec 20, 2026Jardiance (empagliflozin)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)204629
Dec 20, 2026Jentadueto (linagliptin; metformin hydrochloride)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)201281
Dec 20, 2026Jentadueto Xr (linagliptin; metformin hydrochloride)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)208026
Dec 20, 2026Synjardy (empagliflozin; metformin hydrochloride)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)206111
Dec 20, 2026Synjardy Xr (empagliflozin; metformin hydrochloride)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)208658
Dec 20, 2026Tissueblue (brilliant blue g)Dutch Ophthalmic Research Center InternaODE-282 (orphan drug)209569
Dec 20, 2026Tradjenta (linagliptin)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)201280
Dec 22, 2026Leqvio (inclisiran sodium)Novartis Pharmaceuticals CorpNCE (new chemical entity)214012
Dec 27, 2026Lynparza (olaparib)Astrazeneca Pharmaceuticals LpODE-283 (orphan drug)208558
Dec 30, 2026Recorlev (levoketoconazole)Strongbridge Dublin LtdNCE* (new chemical entity)214133

2027 · 225 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Jan 3, 2027Nucynta (tapentadol hydrochloride)Collegium Pharmaceutical IncPED (pediatric)203794
Jan 3, 2027Nucynta (tapentadol hydrochloride)Collegium Pharmaceutical IncPED (pediatric)022304
Jan 8, 2027Provayblue (methylene blue)Provepharm SasM-303 (miscellaneous)204630
Jan 9, 2027Ayvakit (avapritinib)Blueprint Medicines CorpODE-366 (orphan drug)212608
Jan 10, 2027Valtoco (diazepam)Neurelis IncODE-279 (orphan drug)211635
Jan 13, 2027Veklury (remdesivir)Gilead Sciences IncPED (pediatric)214787
Jan 14, 2027Cibinqo (abrocitinib)Pfizer IncNCE (new chemical entity)213871
Jan 18, 2027Piqray (alpelisib)Novartis Pharmaceuticals CorpI-937 (new indication)212526
Jan 19, 2027Balversa (erdafitinib)Janssen Biotech IncI-930 (new indication)212018
Jan 19, 2027Otezla (apremilast)Amgen IncPED (pediatric)205437
Jan 19, 2027Otezla Xr (apremilast)Amgen IncPED (pediatric)210745
Jan 20, 2027Otezla (apremilast)Amgen IncPED (pediatric)205437
Jan 20, 2027Otezla Xr (apremilast)Amgen IncPED (pediatric)210745
Jan 23, 2027Tazverik (tazemetostat hydrobromide)Epizyme IncODE-299 (orphan drug)211723
Jan 23, 2027Zynrelef Kit (bupivacaine; meloxicam)Heron Therapeutics IncI-933 (new indication)211988
Jan 24, 2027Dificid (fidaxomicin)Cubist Pharmaceuticals LlcODE-367 (orphan drug)201699
Jan 24, 2027Dificid (fidaxomicin)Cubist Pharmaceuticals LlcODE-367 (orphan drug)213138
Jan 26, 2027Avycaz (avibactam sodium; ceftazidime)Abbvie IncNPP (new patient population)206494
Feb 9, 2027Eohilia (budesonide)Takeda Pharmaceuticals Usa IncNP (new product)213976
Feb 13, 2027Aurlumyn (iloprost)Btg International IncNP (new product)217933
Feb 13, 2027Legubeti (acetylcysteine lysine)Galephar Pharmaceutical Research IncNP (new product)215040
Feb 13, 2027Onivyde (irinotecan hydrochloride)Ipsen Biopharmaceuticals IncI-932 (new indication)207793
Feb 16, 2027Tagrisso (osimertinib mesylate)Astrazeneca Pharmaceuticals LpI-941 (new indication)208065
Feb 17, 2027Pyrukynd (mitapivat sulfate)Agios Pharmaceuticals IncNCE (new chemical entity)216196
Feb 23, 2027Biktarvy (bictegravir sodium; emtricitabine; tenofovir alafenamide fum)Gilead Sciences IncI-942 (new indication)210251
Feb 23, 2027Trintellix (vortioxetine hydrobromide)Takeda Pharmaceuticals Usa IncPED (pediatric)204447
Feb 28, 2027Veklury (remdesivir)Gilead Sciences IncNPP (new patient population)214787
Feb 28, 2027Vonjo (pacritinib citrate)Sobi IncNCE (new chemical entity)208712
Mar 4, 2027Byqlovi (clobetasol propionate)Harrow Eye LlcNP (new product)218158
Mar 6, 2027Isturisa (osilodrostat phosphate)Recordati Rare Diseases IncODE-286 (orphan drug)212801
Mar 6, 2027Ofev (nintedanib esylate)Boehringer Ingelheim Pharmaceuticals IncPED (pediatric)205832
Mar 7, 2027Brukinsa (zanubrutinib)Beone Medicines Usa IncI-936 (new indication)213217
Mar 7, 2027Brukinsa (zanubrutinib)Beone Medicines Usa IncI-936 (new indication)218785
Mar 8, 2027Wegovy (semaglutide)Novo Nordisk IncI-935 (new indication)215256
Mar 8, 2027Wegovy (semaglutide)Novo Nordisk IncI-935 (new indication)218316
Mar 13, 2027Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncI-938 (new indication)214662
Mar 13, 2027Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncI-938 (new indication)219485
Mar 15, 2027Edurant (rilpivirine hydrochloride)Janssen Products LpNPP (new patient population)202022
Mar 15, 2027Edurant Ped (rilpivirine hydrochloride)Janssen Products LpNP (new product)219016
Mar 15, 2027Xhance (fluticasone propionate)Paratek Pharmaceuticals IncI-940 (new indication)209022
Mar 19, 2027Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncODE-293 (orphan drug)208341
Mar 19, 2027Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncODE* (orphan drug)214187
Mar 19, 2027Iclusig (ponatinib hydrochloride)Takeda Pharmaceuticals Usa IncI-934 (new indication)203469
Mar 22, 2027Nexletol (bempedoic acid)Esperion Therapeutics IncI-943 (new indication)211616
Mar 22, 2027Nexletol (bempedoic acid)Esperion Therapeutics IncI-944 (new indication)211616
Mar 22, 2027Nexlizet (bempedoic acid; ezetimibe)Esperion Therapeutics IncI-943 (new indication)211617
Mar 22, 2027Nexlizet (bempedoic acid; ezetimibe)Esperion Therapeutics IncI-945 (new indication)211617
Mar 22, 2027Opsynvi (macitentan; tadalafil)Actelion Pharmaceuticals Us IncNP (new product)218490
Mar 23, 2027Pluvicto (lutetium lu-177 vipivotide tetraxetan)Novartis Pharmaceuticals CorpNCE (new chemical entity)215833
Mar 26, 2027Bosulif (bosutinib monohydrate)Pf Prism CvPED (pediatric)217729
Mar 26, 2027Bosulif (bosutinib monohydrate)Pf Prism CvPED (pediatric)203341
Mar 27, 2027Vemlidy (tenofovir alafenamide fumarate)Gilead Sciences IncNPP (new patient population)208464
Mar 29, 2027Risvan (risperidone)Laboratorios Farmaceuticos Rovi SaNP (new product)214835
Apr 2, 2027Fanapt (iloperidone)Vanda Pharmaceuticals IncI-939 (new indication)022192
Apr 3, 2027Lenvima (lenvatinib mesylate)Eisai IncM-14 (miscellaneous)206947
Apr 4, 2027Xromi (hydroxyurea)Nova Laboratories LtdNP (new product)216593
Apr 5, 2027Dovato (dolutegravir sodium; lamivudine)Viiv Healthcare CoNPP (new patient population)211994
Apr 7, 2027Quviviq (daridorexant hydrochloride)Idorsia Pharmaceuticals LtdNCE (new chemical entity)214985
Apr 10, 2027Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpODE-288 (orphan drug)213756
Apr 10, 2027Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpODE* (orphan drug)219943
Apr 15, 2027Jelmyto (mitomycin)Urogen Pharma LtdODE-289 (orphan drug)211728
Apr 17, 2027Pemazyre (pemigatinib)Incyte CorpODE-292 (orphan drug)213736
Apr 17, 2027Tukysa (tucatinib)Seagen IncODE-309 (orphan drug)213411
Apr 18, 2027Alecensa (alectinib hydrochloride)Hoffmann-la Roche IncI-947 (new indication)208434
Apr 19, 2027Rezenopy (naloxone hydrochloride)Scienture LlcNP (new product)215487
Apr 23, 2027Lutathera (lutetium lu 177 dotatate)Advanced Accelerator Applications Usa InNPP (new patient population)208700
Apr 24, 2027Biktarvy (bictegravir sodium; emtricitabine; tenofovir alafenamide fum)Gilead Sciences IncM-305 (miscellaneous)210251
Apr 24, 2027Clinolipid 20% (olive oil; soybean oil)Baxter Healthcare CorpNPP (new patient population)204508
Apr 25, 2027Otezla (apremilast)Amgen IncNPP (new patient population)205437
Apr 26, 2027Rinvoq (upadacitinib)Abbvie IncI-946 (new indication)211675
Apr 26, 2027Rinvoq (upadacitinib)Abbvie IncNPP (new patient population)211675
Apr 26, 2027Rinvoq Lq (upadacitinib)Abbvie IncNP (new product)218347
Apr 26, 2027Vivjoa (oteseconazole)Mycovia Pharmaceuticals IncNCE (new chemical entity)215888
Apr 28, 2027Camzyos (mavacamten)Bristol Myers Squibb CoNCE (new chemical entity)214998
Apr 29, 2027Zejula (niraparib tosylate)Glaxosmithkline LlcODE-295 (orphan drug)208447
May 3, 2027Voquezna (vonoprazan fumarate)Phathom Pharmaceuticals IncNCE (new chemical entity)215151
May 3, 2027Voquezna Dual Pak (amoxicillin; vonoprazan fumarate)Phathom Pharmaceuticals IncNCE (new chemical entity)215153
May 3, 2027Voquezna Triple Pak (amoxicillin; clarithromycin; vonoprazan fumarate)Phathom Pharmaceuticals IncNCE (new chemical entity)215152
May 6, 2027Tabrecta (capmatinib hydrochloride)Novartis Pharmaceutical CorpODE-291 (orphan drug)213591
May 8, 2027Lynparza (olaparib)Astrazeneca Pharmaceuticals LpODE-306 (orphan drug)208558
May 8, 2027Retevmo (selpercatinib)Eli Lilly And CoODE-301 (orphan drug)213246
May 8, 2027Retevmo (selpercatinib)Eli Lilly And CoODE-302 (orphan drug)213246
May 8, 2027Retevmo (selpercatinib)Eli Lilly And CoODE-303 (orphan drug)213246
May 8, 2027Retevmo (selpercatinib)Eli Lilly And CoODE* (orphan drug)218160
May 8, 2027Rexulti (brexpiprazole)Otsuka Pharmaceutical Co LtdM-14 (miscellaneous)205422
May 13, 2027Mounjaro (autoinjector) (tirzepatide)Eli Lilly And CoNCE (new chemical entity)215866
May 13, 2027Zepbound (autoinjector) (tirzepatide)Eli Lilly And CoNCE (new chemical entity)217806
May 14, 2027Pomalyst (pomalidomide)Bristol Myers Squibb CoODE-296 (orphan drug)204026
May 14, 2027Pomalyst (pomalidomide)Bristol Myers Squibb CoODE-297 (orphan drug)204026
May 15, 2027Qinlock (ripretinib)Deciphera Pharmaceuticals LlcODE-298 (orphan drug)213973
May 22, 2027Alunbrig (brigatinib)Takeda Pharmaceuticals Usa IncODE-300 (orphan drug)208772
May 23, 2027Vtama (tapinarof)Organon LlcNCE (new chemical entity)215272
May 26, 2027Artesunate (artesunate)Amivas IncODE-290 (orphan drug)213036
May 27, 2027Sirturo (bedaquiline fumarate)Janssen Therapeutics Div Janssen ProductODE-307 (orphan drug)204384
May 29, 2027Retevmo (selpercatinib)Eli Lilly And CoNPP (new patient population)213246
Jun 1, 2027Ztalmy (ganaxolone)Immedica Pharma AbNCE (new chemical entity)215904
Jun 7, 2027Klisyri (tirbanibulin)Almirall LlcD-192 (new dosing schedule)213189
Jun 8, 2027Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncPED (pediatric)207500
Jun 8, 2027Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncPED (pediatric)207501
Jun 12, 2027Farxiga (dapagliflozin)Astrazeneca AbNPP (new patient population)202293
Jun 12, 2027Xigduo Xr (dapagliflozin; metformin hydrochloride)Astrazeneca AbNPP (new patient population)205649
Jun 13, 2027Amvuttra (vutrisiran sodium)Alnylam Pharmaceuticals IncNCE (new chemical entity)215515
Jun 15, 2027Zepzelca (lurbinectedin)Jazz Pharmaceuticals Ireland LtdODE-304 (orphan drug)213702
Jun 18, 2027Tazverik (tazemetostat hydrobromide)Epizyme IncODE-314 (orphan drug)211723
Jun 19, 2027Baxdela (delafloxacin meglumine)Melinta Subsidiary CorpGAIN (qualified infectious disease product (GAIN))208611
Jun 19, 2027Baxdela (delafloxacin meglumine)Melinta Subsidiary CorpGAIN (qualified infectious disease product (GAIN))208610
Jun 21, 2027Sirturo (bedaquiline fumarate)Janssen Therapeutics Div Janssen ProductM-306 (miscellaneous)204384
Jun 21, 2027Wakix (pitolisant hydrochloride)Harmony Biosciences Management IncNPP (new patient population)211150
Jun 22, 2027Xpovio (selinexor)Karyopharm Therapeutics IncODE-310 (orphan drug)212306
Jun 22, 2027Xpovio (selinexor)Karyopharm Therapeutics IncODE* (orphan drug)212306
Jun 25, 2027Fintepla (fenfluramine hydrochloride)Ucb IncODE-312 (orphan drug)212102
Jun 26, 2027Mycapssa (octreotide acetate)Chiesi Farmaceutici SpaODE-474 (orphan drug)208232
Jun 28, 2027Paragard T 380a (copper)Coopersurgical IncD-193 (new dosing schedule)018680
Jun 30, 2027Dojolvi (triheptanoin)Ultragenyx Pharmaceutical IncODE-311 (orphan drug)213687
Jul 1, 2027Velphoro (ferric oxyhydroxide)Vifor Fresenius Medical Care Renal PharmNPP (new patient population)205109
Jul 7, 2027Inqovi (cedazuridine; decitabine)Taiho Oncology IncODE-316 (orphan drug)212576
Jul 8, 2027Bludigo (indigotindisulfonate sodium)Provepharm SasNCE (new chemical entity)216264
Jul 9, 2027Zoryve (roflumilast)Arcutis Biotherapeutics IncNS (new strength)215985
Jul 17, 2027Voquezna (vonoprazan fumarate)Phathom Pharmaceuticals IncI-948 (new indication)215151
Jul 21, 2027Xywav (calcium oxybate; magnesium oxybate; potassium oxybate; sodiu)Jazz Pharmaceuticals Ireland LtdODE-361 (orphan drug)212690
Jul 22, 2027Femlyv (ethinyl estradiol; norethindrone acetate)Millicent Manufacturing Pr LlcNP (new product)218718
Jul 31, 2027Epidiolex (cannabidiol)Jazz Pharmaceuticals Research Uk LtdODE-326 (orphan drug)210365
Jul 31, 2027Epidiolex (cannabidiol)Jazz Pharmaceuticals Research Uk LtdODE-332 (orphan drug)210365
Aug 5, 2027Suprep Bowel Prep Kit (magnesium sulfate; potassium sulfate; sodium sulfate)Azurity Pharmaceuticals IncODE-315 (orphan drug)022372
Aug 6, 2027Lampit (nifurtimox)Bayer Healthcare Pharmaceuticals IncODE-319 (orphan drug)213464
Aug 7, 2027Crexont (carbidopa; levodopa)Impax Laboratories LlcNP (new product)217186
Aug 7, 2027Evrysdi (risdiplam)Genentech IncODE-334 (orphan drug)213535
Aug 7, 2027Fabhalta (iptacopan hydrochloride)Novartis Pharmaceuticals CorpI-949 (new indication)218276
Aug 7, 2027Zurnai (autoinjector) (nalmefene hydrochloride)Knoa Pharma LlcNP (new product)218590
Aug 12, 2027Protonix Iv (pantoprazole sodium)Wyeth Pharmaceuticals LlcNPP (new patient population)020988
Aug 12, 2027Viltepso (viltolarsen)Nippon Shinyaku Co LtdODE-280 (orphan drug)212154
Aug 28, 2027Veklury (remdesivir)Gilead Sciences IncPED (pediatric)214787
Aug 29, 2027Vabomere (meropenem; vaborbactam)Rempex Pharmaceuticals Inc A Wholly OwneGAIN (qualified infectious disease product (GAIN))209776
Aug 30, 2027Prevymis (letermovir)Merck Sharp And Dohme CorpNPP (new patient population)209939
Aug 30, 2027Prevymis (letermovir)Merck Sharp And Dohme CorpNPP (new patient population)209940
Aug 30, 2027Prevymis (letermovir)Merck Sharp And Dohme LlcNP (new product)219104
Aug 30, 2027Zeposia (ozanimod hydrochloride)Bristol Myers Squibb CoM-309 (miscellaneous)209899
Sep 1, 2027Onureg (azacitidine)Bristol Myers Squibb CoODE-320 (orphan drug)214120
Sep 3, 2027Detectnet (copper cu-64 dotatate)Curium Us LlcODE-317 (orphan drug)213227
Sep 4, 2027Gavreto (pralsetinib)Rigel Pharmaceuticals IncODE-318 (orphan drug)213721
Sep 6, 2027Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncGAIN (qualified infectious disease product (GAIN))207500
Sep 6, 2027Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncGAIN (qualified infectious disease product (GAIN))207501
Sep 9, 2027Sotyktu (deucravacitinib)Bristol Myers Squibb CoNCE (new chemical entity)214958
Sep 13, 2027Qsymia (phentermine hydrochloride; topiramate)Vivus LlcM-308 (miscellaneous)022580
Sep 14, 2027Terlivaz (terlipressin acetate)Mallinckrodt Pharmaceuticals Ireland LtdNCE (new chemical entity)022231
Sep 15, 2027Edurant (rilpivirine hydrochloride)Janssen Products LpPED (pediatric)202022
Sep 15, 2027Edurant Ped (rilpivirine hydrochloride)Janssen Products LpPED (pediatric)219016
Sep 15, 2027Solosec (secnidazole)Evofem IncGAIN (qualified infectious disease product (GAIN))209363
Sep 17, 2027Kisqali (ribociclib succinate)Novartis Pharmaceuticals CorpI-950 (new indication)209092
Sep 17, 2027Kisqali Femara Co-pack (copackaged) (letrozole; ribociclib succinate)Novartis Pharmaceuticals CorpI-951 (new indication)209935
Sep 19, 2027Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncPED (pediatric)208341
Sep 19, 2027Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncPED (pediatric)214187
Sep 21, 2027Elucirem (gadopiclenol)GuerbetNCE (new chemical entity)216986
Sep 22, 2027Omlonti (omidenepag isopropyl)Ocuvex Therapeutics IncNCE (new chemical entity)215092
Sep 22, 2027Opsynvi (macitentan; tadalafil)Actelion Pharmaceuticals Us IncPED (pediatric)218490
Sep 25, 2027Tagrisso (osimertinib mesylate)Astrazeneca Pharmaceuticals LpI-952 (new indication)208065
Sep 27, 2027Retevmo (selpercatinib)Eli Lilly And CoM-311 (miscellaneous)213246
Sep 27, 2027Retevmo (selpercatinib)Eli Lilly And CoM-312 (miscellaneous)213246
Sep 27, 2027Retevmo (selpercatinib)Eli Lilly And CoM-311 (miscellaneous)218160
Sep 27, 2027Retevmo (selpercatinib)Eli Lilly And CoM-312 (miscellaneous)218160
Sep 29, 2027Relyvrio (sodium phenylbutyrate; taurursodiol)Amylyx Pharmaceuticals IncNCE (new chemical entity)216660
Sep 30, 2027Lytgobi (futibatinib)Taiho Oncology IncNCE (new chemical entity)214801
Sep 30, 2027Quviviq (daridorexant hydrochloride)Idorsia Pharmaceuticals LtdM-200 (miscellaneous)214985
Sep 30, 2027Quviviq (daridorexant hydrochloride)Idorsia Pharmaceuticals LtdM-310 (miscellaneous)214985
Oct 3, 2027Lenvima (lenvatinib mesylate)Eisai IncPED (pediatric)206947
Oct 4, 2027Ameluz (aminolevulinic acid hydrochloride)Biofrontera IncD-194 (new dosing schedule)208081
Oct 11, 2027Kombiglyze Xr (metformin hydrochloride; saxagliptin hydrochloride)Astrazeneca AbM-14 (miscellaneous)200678
Oct 11, 2027Onglyza (saxagliptin hydrochloride)Astrazeneca AbM-14 (miscellaneous)022350
Oct 13, 2027Wakix (pitolisant hydrochloride)Harmony Biosciences Management IncODE-331 (orphan drug)211150
Oct 16, 2027Vyalev (foscarbidopa; foslevodopa)Abbvie IncNP (new product)216962
Oct 18, 2027Zepbound (autoinjector) (tirzepatide)Eli Lilly And CoM-82 (miscellaneous)217806
Oct 23, 2027Lutathera (lutetium lu 177 dotatate)Advanced Accelerator Applications Usa InPED (pediatric)208700
Oct 25, 2027Otezla (apremilast)Amgen IncPED (pediatric)205437
Oct 29, 2027Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpI-953 (new indication)215358
Oct 29, 2027Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpI-954 (new indication)215358
Oct 30, 2027Bronchitol (mannitol)Pharmaxis Europe LtdODE-327 (orphan drug)202049
Nov 1, 2027Emrosi (minocycline hydrochloride)Journey Medical CorpNP (new product)219015
Nov 1, 2027Talicia (amoxicillin; omeprazole magnesium; rifabutin)Talicia Holdings IncGAIN (qualified infectious disease product (GAIN))213004
Nov 8, 2027Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)213246
Nov 8, 2027Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)218160
Nov 8, 2027Rexulti (brexpiprazole)Otsuka Pharmaceutical Co LtdPED (pediatric)205422
Nov 14, 2027Pomalyst (pomalidomide)Bristol Myers Squibb CoPED (pediatric)204026
Nov 20, 2027Zokinvy (lonafarnib)Sentynl Therapeutics IncODE-324 (orphan drug)213969
Nov 23, 2027Oxlumo (lumasiran sodium)Alnylam Pharmaceuticals IncODE-339 (orphan drug)214103
Nov 25, 2027Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncODE-336 (orphan drug)213793
Nov 26, 2027Acetadote (acetylcysteine)Apotex IncD-196 (new dosing schedule)021539
Nov 29, 2027Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)213246
Dec 1, 2027Gavreto (pralsetinib)Rigel Pharmaceuticals IncODE-340 (orphan drug)213721
Dec 1, 2027Gavreto (pralsetinib)Rigel Pharmaceuticals IncODE-341 (orphan drug)213721
Dec 1, 2027Hetlioz (tasimelteon)Vanda Pharmaceuticals IncODE-330 (orphan drug)205677
Dec 1, 2027Hetlioz Lq (tasimelteon)Vanda Pharmaceuticals IncODE-329 (orphan drug)214517
Dec 1, 2027Rezlidhia (olutasidenib)Rigel Pharmaceuticals IncNCE (new chemical entity)215814
Dec 3, 2027Orladeyo (berotralstat dihydrochloride)Biocryst Pharmaceuticals IncODE-333 (orphan drug)214094
Dec 12, 2027Bridion (sugammadex sodium)Merck Sharp And Dohme Llc A Sub Of MerckNPP (new patient population)022225
Dec 12, 2027Farxiga (dapagliflozin)Astrazeneca AbPED (pediatric)202293
Dec 12, 2027Krazati (adagrasib)Bristol Myers Squibb CoNCE (new chemical entity)216340
Dec 12, 2027Vtama (tapinarof)Organon LlcI-956 (new indication)215272
Dec 12, 2027Xigduo Xr (dapagliflozin; metformin hydrochloride)Astrazeneca AbPED (pediatric)205649
Dec 13, 2027Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals IncM-14 (miscellaneous)211358
Dec 18, 2027Gemtesa (vibegron)Sumitomo Pharma America IncI-955 (new indication)213006
Dec 18, 2027Invokamet (canagliflozin; metformin hydrochloride)Janssen Pharmaceuticals IncNPP (new patient population)204353
Dec 18, 2027Invokamet Xr (canagliflozin; metformin hydrochloride)Janssen Pharmaceuticals IncNPP (new patient population)205879
Dec 18, 2027Invokana (canagliflozin)Janssen Pharmaceuticals IncNPP (new patient population)204042
Dec 18, 2027Tagrisso (osimertinib mesylate)Astrazeneca Pharmaceuticals LpODE-337 (orphan drug)208065
Dec 18, 2027Xpovio (selinexor)Karyopharm Therapeutics IncODE-346 (orphan drug)212306
Dec 18, 2027Xpovio (selinexor)Karyopharm Therapeutics IncODE* (orphan drug)212306
Dec 19, 2027Xofluza (baloxavir marboxil)Genentech IncM-187 (miscellaneous)210854
Dec 19, 2027Xofluza (baloxavir marboxil)Genentech IncM-187 (miscellaneous)214410
Dec 20, 2027Braftovi (encorafenib)Array Biopharma IncI-957 (new indication)210496
Dec 20, 2027Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncNPP (new patient population)213793
Dec 20, 2027Skyclarys (omaveloxolone)Biogen Us CorporationM-270 (miscellaneous)216718
Dec 20, 2027Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncM-313 (miscellaneous)212273
Dec 20, 2027Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncM-313 (miscellaneous)217660
Dec 20, 2027Zepbound (autoinjector) (tirzepatide)Eli Lilly And CoI-958 (new indication)217806
Dec 21, 2027Kalydeco (ivacaftor)Vertex Pharmaceuticals IncODE-338 (orphan drug)203188
Dec 21, 2027Kalydeco (ivacaftor)Vertex Pharmaceuticals IncODE-338 (orphan drug)207925
Dec 21, 2027Symdeko (copackaged) (ivacaftor; ivacaftor, tezacaftor)Vertex Pharmaceuticals IncODE-335 (orphan drug)210491
Dec 21, 2027Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-323 (orphan drug)212273
Dec 21, 2027Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE* (orphan drug)212273
Dec 22, 2027Sunlenca (lenacapavir sodium)Gilead Sciences IncNCE (new chemical entity)215973
Dec 22, 2027Sunlenca (lenacapavir sodium)Gilead Sciences IncNCE (new chemical entity)215974
Dec 22, 2027Yeztugo (lenacapavir sodium)Gilead Sciences IncNCE (new chemical entity)220018
Dec 22, 2027Yeztugo (lenacapavir sodium)Gilead Sciences IncNCE (new chemical entity)220020
Dec 23, 2027Xenoview (xenon xe-129 hyperpolarized)Polarean IncNCE (new chemical entity)214375
Dec 25, 2027Fintepla (fenfluramine hydrochloride)Ucb IncPED (pediatric)212102

2028 · 233 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Jan 1, 2028Velphoro (ferric oxyhydroxide)Vifor Fresenius Medical Care Renal PharmPED (pediatric)205109
Jan 14, 2028Xalkori (crizotinib)Pf Prism CvODE-328 (orphan drug)202570
Jan 16, 2028Calquence (acalabrutinib)Astrazeneca Uk LtdI-960 (new indication)210259
Jan 16, 2028Calquence (acalabrutinib maleate)Astrazeneca Uk LtdI-960 (new indication)216387
Jan 16, 2028Lumakras (sotorasib)Amgen IncI-962 (new indication)214665
Jan 17, 2028Spravato (esketamine hydrochloride)Janssen Pharmaceuticals IncI-959 (new indication)211243
Jan 20, 2028Brenzavvy (bexagliflozin)Theracosbio LlcNCE (new chemical entity)214373
Jan 21, 2028Xywav (calcium oxybate; magnesium oxybate; potassium oxybate; sodiu)Jazz Pharmaceuticals Ireland LtdPED (pediatric)212690
Jan 22, 2028Carbaglu (carglumic acid)Recordati Rare Diseases IncODE-345 (orphan drug)022562
Jan 27, 2028Jaypirca (pirtobrutinib)Loxo Oncology IncNCE (new chemical entity)216059
Jan 27, 2028Orserdu (elacestrant hydrochloride)Stemline Therapeutics IncNCE (new chemical entity)217639
Jan 28, 2028Ozempic (semaglutide)Novo Nordisk IncI-961 (new indication)209637
Jan 30, 2028Symbravo (meloxicam; rizatriptan benzoate)Axsome Therapeutics IncNP (new product)215431
Jan 31, 2028Paxlovid (copackaged) (nirmatrelvir; ritonavir)Pfizer IncD-195 (new dosing schedule)217188
Feb 1, 2028Jesduvroq (daprodustat)Glaxosmithkline Intellectual Property NoNCE (new chemical entity)216951
Feb 3, 2028Onapgo (apomorphine hydrochloride)Mdd Us Operations Llc A Sub Of Supernus NP (new product)214056
Feb 3, 2028Tepmetko (tepotinib hydrochloride)Emd Serono IncODE-325 (orphan drug)214096
Feb 7, 2028Emblaveo (avibactam sodium; aztreonam)Abbvie IncNP (new product)217906
Feb 7, 2028Moxidectin (moxidectin)Medicines Development For Global HealthNPP (new patient population)210867
Feb 17, 2028Filspari (sparsentan)Travere Therapeutics IncNCE (new chemical entity)216403
Feb 21, 2028Ctexli (chenodiol)Mirum Pharmaceuticals IncNP (new product)219488
Feb 21, 2028Sublocade (buprenorphine)Indivior IncM-314 (miscellaneous)209819
Feb 21, 2028Xeljanz (tofacitinib citrate)Pf Prism CvM-14 (miscellaneous)203214
Feb 21, 2028Xeljanz (tofacitinib citrate)Pfizer IncM-14 (miscellaneous)213082
Feb 24, 2028Miudella (copper)Sebela Womens Health IncNP (new product)218201
Feb 25, 2028Amondys 45 (casimersen)Sarepta Therapeutics IncODE-347 (orphan drug)213026
Feb 26, 2028Nulibry (fosdenopterin hydrobromide)Sentynl Therapeutics IncODE-342 (orphan drug)214018
Feb 28, 2028Opsumit (macitentan)Actelion Pharmaceuticals Us IncM-187 (miscellaneous)204410
Feb 28, 2028Skyclarys (omaveloxolone)Biogen Us CorporationNCE (new chemical entity)216718
Mar 3, 2028Lorbrena (lorlatinib)Pfizer IncODE-349 (orphan drug)210868
Mar 9, 2028Zavzpret (zavegepant hydrochloride)Pfizer IncNCE (new chemical entity)216386
Mar 10, 2028Daybue (trofinetide)Acadia Pharmaceuticals IncNCE (new chemical entity)217026
Mar 10, 2028Daybue Stix (trofinetide)Acadia Pharmaceuticals IncNCE (new chemical entity)219884
Mar 17, 2028Baqsimi (glucagon)Amphastar Pharmaceuticals IncNPP (new patient population)210134
Mar 17, 2028Kisqali (ribociclib succinate)Novartis Pharmaceuticals CorpPED (pediatric)209092
Mar 17, 2028Kisqali Femara Co-pack (copackaged) (letrozole; ribociclib succinate)Novartis Pharmaceuticals CorpPED (pediatric)209935
Mar 20, 2028Amvuttra (vutrisiran sodium)Alnylam Pharmaceuticals IncI-964 (new indication)215515
Mar 20, 2028Fabhalta (iptacopan hydrochloride)Novartis Pharmaceuticals CorpI-963 (new indication)218276
Mar 22, 2028Rezzayo (rezafungin acetate)Mundipharma GmbhNCE (new chemical entity)217417
Mar 24, 2028Joenja (leniolisib phosphate)Pharming Technologies BvNCE (new chemical entity)217759
Mar 26, 2028Vykat Xr (diazoxide choline)Soleno Therapeutics IncNP (new product)216665
Mar 27, 2028Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)213246
Mar 27, 2028Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)218160
Mar 27, 2028Rivfloza (nedosiran sodium)Novo Nordisk IncNPP (new patient population)215842
Mar 28, 2028Pluvicto (lutetium lu-177 vipivotide tetraxetan)Novartis Pharmaceuticals CorpI-965 (new indication)215833
Mar 30, 2028Vyxeos (cytarabine; daunorubicin)Jazz Pharmaceuticals Therapeutics IncODE-350 (orphan drug)209401
Apr 4, 2028Sivextro (tedizolid phosphate)Cubist Pharmaceuticals LlcNPP (new patient population)205435
Apr 4, 2028Sivextro (tedizolid phosphate)Cubist Pharmaceuticals LlcNPP (new patient population)205436
Apr 7, 2028Dextenza (dexamethasone)Ocular Therapeutix IncNPP (new patient population)208742
Apr 15, 2028Valtoco (diazepam)Neurelis IncNPP (new patient population)211635
Apr 17, 2028Eliquis (apixaban)Bristol Myers Squibb Co Pharmaceutical RNPP (new patient population)202155
Apr 17, 2028Eliquis (apixaban)Bristol Myers Squibb Co Pharmaceutical RNS (new strength)202155
Apr 17, 2028Eliquis Sprinkle (apixaban)Bristol Myers Squibb CoNP (new product)220073
Apr 25, 2028Qalsody (tofersen)Biogen Ma IncNCE (new chemical entity)215887
Apr 28, 2028Rinvoq (upadacitinib)Abbvie IncI-966 (new indication)211675
Apr 30, 2028Atzumi (dihydroergotamine mesylate)Satsuma Pharmaceuticals IncNP (new product)217901
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-417 (orphan drug)021825
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-420 (orphan drug)021825
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-421 (orphan drug)021825
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-417 (orphan drug)208030
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-418 (orphan drug)208030
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-419 (orphan drug)208030
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-417 (orphan drug)212269
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-420 (orphan drug)212269
Apr 30, 2028Ferriprox (deferiprone)Chiesi Usa IncODE-421 (orphan drug)212269
May 9, 2028Optison (albumin human)Ge HealthcareNPP (new patient population)020899
May 9, 2028Rexulti (brexpiprazole)Otsuka Pharmaceutical Co LtdM-315 (miscellaneous)205422
May 12, 2028Veozah (fezolinetant)Astellas Pharma Us IncNCE (new chemical entity)216578
May 14, 2028Empaveli (pegcetacoplan)Apellis Pharmaceuticals IncODE-351 (orphan drug)215014
May 14, 2028Welireg (belzutifan)Merck Sharp And Dohme Corp A Sub Of MercI-968 (new indication)215383
May 18, 2028Miebo (perfluorohexyloctane)Bausch And Lomb IncNCE (new chemical entity)216675
May 22, 2028Kalydeco (ivacaftor)Vertex Pharmaceuticals IncM-14 (miscellaneous)207925
May 22, 2028Kyprolis (carfilzomib)Onyx Pharmaceuticals Inc A Wholly Owned M-14 (miscellaneous)202714
May 22, 2028Zoryve (roflumilast)Arcutis Biotherapeutics IncI-969 (new indication)217242
May 23, 2028Xacduro (copackaged) (durlobactam sodium; durlobactam sodium; sulbactam sodium)Entasis Therapeutics IncNCE (new chemical entity)216974
May 23, 2028Yutrepia (treprostinil sodium)Liquidia Technologies IncNP (new product)213005
May 25, 2028Paxlovid (copackaged) (nirmatrelvir; ritonavir)Pfizer IncNCE (new chemical entity)217188
May 25, 2028Posluma (flotufolastat f-18 gallium)Blue Earth Diagnostics LtdNCE (new chemical entity)216023
May 26, 2028Inpefa (sotagliflozin)Lexicon Pharmaceuticals IncNCE (new chemical entity)216203
May 28, 2028Lumakras (sotorasib)Amgen IncODE-352 (orphan drug)214665
May 28, 2028Lumakras (sotorasib)Amgen IncODE* (orphan drug)214665
May 28, 2028Truseltiq (infigratinib phosphate)Helsinn Healthcare SaODE-353 (orphan drug)214622
Jun 3, 2028Nubeqa (darolutamide)Bayer Healthcare Pharmaceuticals IncI-971 (new indication)212099
Jun 3, 2028Orladeyo (berotralstat dihydrochloride)Biocryst Pharmaceuticals IncPED (pediatric)214094
Jun 4, 2028Tembexa (brincidofovir)Emergent Biodefense Operations Lansing LODE-354 (orphan drug)214460
Jun 4, 2028Tembexa (brincidofovir)Emergent Biodefense Operations Lansing IODE-354 (orphan drug)214461
Jun 5, 2028Widaplik (amlodipine besylate; indapamide; telmisartan)Azurity Pharmaceuticals IncNP (new product)219423
Jun 8, 2028Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-357 (orphan drug)212273
Jun 10, 2028Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncODE-376 (orphan drug)214187
Jun 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncI-967 (new indication)209394
Jun 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncODE-372 (orphan drug)209394
Jun 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncI-967 (new indication)215110
Jun 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncODE-372 (orphan drug)215110
Jun 11, 2028Hectorol (doxercalciferol)Sanofi GenzymeM-14 (miscellaneous)020862
Jun 12, 2028Bridion (sugammadex sodium)Merck Sharp And Dohme Llc A Sub Of MerckPED (pediatric)022225
Jun 12, 2028Zusduri (mitomycin)Urogen Pharma LtdNP (new product)215793
Jun 13, 2028Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals IncPED (pediatric)211358
Jun 16, 2028Ayvakit (avapritinib)Blueprint Medicines CorpODE-356 (orphan drug)212608
Jun 17, 2028Noxafil (posaconazole)Merck Sharp And Dohme CorpODE-355 (orphan drug)205053
Jun 17, 2028Noxafil (posaconazole)Merck Sharp And Dohme CorpODE-355 (orphan drug)205596
Jun 18, 2028Invokamet (canagliflozin; metformin hydrochloride)Janssen Pharmaceuticals IncPED (pediatric)204353
Jun 18, 2028Invokamet Xr (canagliflozin; metformin hydrochloride)Janssen Pharmaceuticals IncPED (pediatric)205879
Jun 18, 2028Invokana (canagliflozin)Janssen Pharmaceuticals IncPED (pediatric)204042
Jun 18, 2028Yeztugo (lenacapavir sodium)Gilead Sciences IncNP (new product)220018
Jun 18, 2028Yeztugo (lenacapavir sodium)Gilead Sciences IncNP (new product)220020
Jun 20, 2028Descovy (emtricitabine; tenofovir alafenamide fumarate)Gilead Sciences IncM-316 (miscellaneous)208215
Jun 20, 2028Tybost (cobicistat)Gilead Sciences IncNPP (new patient population)203094
Jun 20, 2028Tybost (cobicistat)Gilead Sciences IncNS (new strength)203094
Jun 21, 2028Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)203188
Jun 21, 2028Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)207925
Jun 23, 2028Litfulo (ritlecitinib tosylate)Pfizer IncNCE (new chemical entity)215830
Jun 23, 2028Verkazia (cyclosporine)Harrow Eye LlcODE-358 (orphan drug)214965
Jun 25, 2028Zemdri (plazomicin sulfate)Cipla Usa IncGAIN (qualified infectious disease product (GAIN))210303
Jul 10, 2028Motegrity (prucalopride succinate)Takeda Pharmaceuticals Usa IncM-14 (miscellaneous)210166
Jul 11, 2028Kerendia (finerenone)Bayer Healthcare Pharmaceuticals IncI-970 (new indication)215341
Jul 11, 2028Kerendia (finerenone)Bayer Healthcare Pharmaceuticals IncNS (new strength)215341
Jul 16, 2028Fexinidazole (fexinidazole)Sanofi Aventis Us LlcODE-359 (orphan drug)214429
Jul 16, 2028Prograf (tacrolimus)Astellas Pharma Us IncODE-360 (orphan drug)050708
Jul 16, 2028Prograf (tacrolimus)Astellas Pharma Us IncODE-360 (orphan drug)050709
Jul 16, 2028Prograf (tacrolimus)Astellas Pharma Us IncODE-360 (orphan drug)210115
Jul 16, 2028Rezurock (belumosudil mesylate)Kadmon Pharmaceuticals LlcODE-362 (orphan drug)214783
Jul 20, 2028Bylvay (odevixibat)Ipsen Biopharmaceuticals IncODE-363 (orphan drug)215498
Jul 20, 2028Vanflyta (quizartinib dihydrochloride)Daiichi Sankyo IncNCE (new chemical entity)216993
Jul 21, 2028Ycanth (cantharidin)Verrica Pharmaceuticals IncNCE (new chemical entity)212905
Jul 24, 2028Doptelet (avatrombopag maleate)Akarx IncI-974 (new indication)210238
Jul 24, 2028Doptelet Sprinkle (avatrombopag maleate)Akarx IncNP (new product)219696
Jul 24, 2028Xdemvy (lotilaner)Tarsus Pharmaceuticals IncNCE (new chemical entity)217603
Jul 28, 2028Empaveli (pegcetacoplan)Apellis Pharmaceuticals IncI-972 (new indication)215014
Jul 28, 2028Sirturo (bedaquiline fumarate)Janssen Therapeutics Div Janssen ProductNPP (new patient population)204384
Aug 12, 2028Xywav (calcium oxybate; magnesium oxybate; potassium oxybate; sodiu)Jazz Pharmaceuticals Ireland LtdODE-369 (orphan drug)212690
Aug 13, 2028Welireg (belzutifan)Merck Sharp And Dohme Corp A Sub Of MercODE-364 (orphan drug)215383
Aug 15, 2028Cyklx (articaine hydrochloride)Thea Pharma IncNP (new product)218643
Aug 15, 2028Tonmya (cyclobenzaprine hydrochloride)Tonix Pharmaceuticals IncNP (new product)219428
Aug 15, 2028Wegovy (semaglutide)Novo Nordisk IncI-973 (new indication)215256
Aug 16, 2028Sohonos (palovarotene)Ipsen Biopharmaceuticals IncNCE (new chemical entity)215559
Aug 21, 2028Xeljanz (tofacitinib citrate)Pf Prism CvPED (pediatric)203214
Aug 21, 2028Xeljanz (tofacitinib citrate)Pfizer IncPED (pediatric)213082
Aug 25, 2028Camcevi Etm (leuprolide mesylate)Accord Biopharma IncNS (new strength)219745
Aug 25, 2028Tibsovo (ivosidenib)Servier Pharmaceuticals LlcODE-368 (orphan drug)211192
Aug 27, 2028Xerava (eravacycline dihydrochloride)Tetraphase Pharmaceuticals IncGAIN (qualified infectious disease product (GAIN))211109
Aug 28, 2028Opsumit (macitentan)Actelion Pharmaceuticals Us IncPED (pediatric)204410
Aug 31, 2028Brukinsa (zanubrutinib)Beone Medicines Usa IncODE-371 (orphan drug)213217
Aug 31, 2028Brukinsa (zanubrutinib)Beone Medicines Usa IncODE* (orphan drug)218785
Sep 8, 2028Aphexda (motixafortide acetate)Ayrmid Pharma LtdNCE (new chemical entity)217159
Sep 9, 2028Inlexzo (gemcitabine hydrochloride)Janssen Biotech IncNP (new product)219683
Sep 9, 2028Zolymbus (bimatoprost)Thea Pharma IncNDF217307
Sep 10, 2028Daybue (trofinetide)Acadia Pharmaceuticals IncPED (pediatric)217026
Sep 10, 2028Daybue Stix (trofinetide)Acadia Pharmaceuticals IncPED (pediatric)219884
Sep 10, 2028Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpNPP (new patient population)213756
Sep 10, 2028Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpNP (new product)219943
Sep 14, 2028Brukinsa (zanubrutinib)Beone Medicines Usa IncODE-370 (orphan drug)213217
Sep 14, 2028Brukinsa (zanubrutinib)Beone Medicines Usa IncODE* (orphan drug)218785
Sep 15, 2028Airsupra (albuterol sulfate; budesonide)Astrazeneca Pharmaceuticals LpM-317 (miscellaneous)214070
Sep 15, 2028Exkivity (mobocertinib succinate)Takeda Pharmaceuticals Usa IncODE-374 (orphan drug)215310
Sep 15, 2028Ojjaara (momelotinib dihydrochloride)Glaxosmithkline LlcNCE (new chemical entity)216873
Sep 16, 2028Ibrance (palbociclib)Pfizer IncM-14 (miscellaneous)207103
Sep 16, 2028Ibrance (palbociclib)Pfizer IncM-14 (miscellaneous)212436
Sep 17, 2028Cabometyx (cabozantinib s-malate)Exelixis IncODE-375 (orphan drug)208692
Sep 18, 2028Opzelura (ruxolitinib phosphate)Incyte CorpNPP (new patient population)215309
Sep 22, 2028Exxua (gepirone hydrochloride)Fabre Kramer Pharmaceuticals IncNCE (new chemical entity)021164
Sep 22, 2028Jakafi (ruxolitinib phosphate)Incyte CorpODE-373 (orphan drug)202192
Sep 22, 2028Jakafi Xr (ruxolitinib phosphate)Incyte CorpODE* (orphan drug)217180
Sep 23, 2028Tasigna (nilotinib hydrochloride)Novartis Pharmaceuticals CorpODE-380 (orphan drug)022068
Sep 24, 2028Bondlido (lidocaine)Medrx Usa IncNP (new product)215029
Sep 26, 2028Clotic (clotrimazole)Carwin Pharmaceutical Associates LlcNP (new product)217628
Sep 29, 2028Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE-379 (orphan drug)214662
Sep 29, 2028Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE* (orphan drug)214662
Sep 29, 2028Rivfloza (nedosiran sodium)Novo Nordisk IncNCE (new chemical entity)215842
Sep 30, 2028Vyxeos (cytarabine; daunorubicin)Jazz Pharmaceuticals Therapeutics IncPED (pediatric)209401
Oct 2, 2028Nuzyra (omadacycline tosylate)Paratek Pharmaceuticals IncGAIN (qualified infectious disease product (GAIN))209816
Oct 2, 2028Nuzyra (omadacycline tosylate)Paratek Pharmaceuticals IncGAIN (qualified infectious disease product (GAIN))209817
Oct 2, 2028Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpM-318 (miscellaneous)215358
Oct 2, 2028Zepzelca (lurbinectedin)Jazz Pharmaceuticals Ireland LtdI-977 (new indication)213702
Oct 4, 2028Zoryve (roflumilast)Arcutis Biotherapeutics IncNS (new strength)215985
Oct 7, 2028Biktarvy (bictegravir sodium; emtricitabine; tenofovir alafenamide fum)Gilead Sciences IncODE-378 (orphan drug)210251
Oct 7, 2028Tavneos (avacopan)Chemocentryx IncODE-377 (orphan drug)214487
Oct 10, 2028Isovue-300 (iopamidol)Bracco Diagnostics IncI-975 (new indication)018735
Oct 12, 2028Velsipity (etrasimod arginine)Pfizer IncNCE (new chemical entity)216956
Oct 16, 2028Ferabright (ferumoxytol)Azurity Pharmaceuticals IncNP (new product)219868
Oct 16, 2028Ztalmy (ganaxolone)Immedica Pharma AbD-197 (new dosing schedule)215904
Oct 17, 2028Eliquis (apixaban)Bristol Myers Squibb Co Pharmaceutical RPED (pediatric)202155
Oct 17, 2028Eliquis Sprinkle (apixaban)Bristol Myers Squibb CoPED (pediatric)220073
Oct 17, 2028Epioxa Hd/epioxa Kit (riboflavin 5'-phosphate sodium)Glaukos CorpNP (new product)219910
Oct 17, 2028Rybelsus (semaglutide)Novo Nordisk IncI-976 (new indication)213051
Oct 17, 2028Zilbrysq (zilucoplan sodium)Ucb IncNCE (new chemical entity)216834
Oct 22, 2028Contepo (fosfomycin disodium)Meitheal Pharmaceuticals IncNP (new product)212271
Oct 26, 2028Agamree (vamorolone)Catalyst Pharmaceuticals IncNCE (new chemical entity)215239
Oct 29, 2028Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpODE-381 (orphan drug)215358
Oct 29, 2028Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpODE-382 (orphan drug)215358
Oct 29, 2028Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpODE* (orphan drug)215358
Oct 31, 2028Zurzuvae (zuranolone)Biogen IncNCE (new chemical entity)217369
Nov 4, 2028Linzess (linaclotide)Abbvie IncNPP (new patient population)202811
Nov 5, 2028Caplyta (lumateperone tosylate)Intra-cellular Therapies IncI-904 (new indication)209500
Nov 8, 2028Fruzaqla (fruquintinib)Takeda Pharmaceuticals Usa IncNCE (new chemical entity)217564
Nov 15, 2028Augtyro (repotrectinib)Bristol Myers Squibb CoNCE (new chemical entity)218213
Nov 15, 2028Defencath (heparin sodium; taurolidine)Cormedix IncNCE (new chemical entity)214520
Nov 16, 2028Aemcolo (rifamycin sodium)Cosmo Technologies LtdGAIN (qualified infectious disease product (GAIN))210910
Nov 16, 2028Truqap (capivasertib)Astrazeneca Pharmaceuticals LpNCE (new chemical entity)218197
Nov 19, 2028Igalmi (dexmedetomidine hydrochloride)Bioxcel Therapeutics IncM-82 (miscellaneous)215390
Nov 19, 2028Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpNPP (new patient population)213756
Nov 19, 2028Koselugo (selumetinib sulfate)Astrazeneca Pharmaceuticals LpNPP (new patient population)219943
Nov 19, 2028Voxzogo (vosoritide)Biomarin Pharmaceutical IncODE-387 (orphan drug)214938
Nov 22, 2028Fyarro (sirolimus)Aadi Biosciences IncODE-386 (orphan drug)213312
Nov 22, 2028Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)207925
Nov 22, 2028Kyprolis (carfilzomib)Onyx Pharmaceuticals Inc A Wholly Owned PED (pediatric)202714
Nov 23, 2028Livtencity (maribavir)Takeda Pharmaceuticals Usa IncODE-388 (orphan drug)215596
Nov 27, 2028Ogsiveo (nirogacestat hydrobromide)Springworks Therapeutics IncNCE (new chemical entity)217677
Nov 29, 2028Cytalux (pafolacianine sodium)On Target Laboratories IncODE-390 (orphan drug)214907
Dec 2, 2028Jaypirca (pirtobrutinib)Loxo Oncology IncI-981 (new indication)216059
Dec 5, 2028Fabhalta (iptacopan hydrochloride)Novartis Pharmaceuticals CorpNCE (new chemical entity)218276
Dec 9, 2028Recarbrio (cilastatin sodium; imipenem; relebactam)Merck Sharp And Dohme Corp A Sub Of MercNPP (new patient population)212819
Dec 10, 2028Epclusa (sofosbuvir; velpatasvir)Gilead Sciences IncPED (pediatric)214187
Dec 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncPED (pediatric)215110
Dec 10, 2028Mavyret (glecaprevir; pibrentasvir)Abbvie IncPED (pediatric)209394
Dec 11, 2028Blujepa (gepotidacin mesylate)Glaxosmithkline LlcI-978 (new indication)218230
Dec 11, 2028Orladeyo (berotralstat dihydrochloride)Biocryst Pharmaceuticals IncNP (new product)219776
Dec 12, 2028Akeega (abiraterone acetate; niraparib tosylate)Janssen Biotech IncI-980 (new indication)216793
Dec 13, 2028Addyi (flibanserin)Sprout Pharmaceuticals IncI-983 (new indication)022526
Dec 15, 2028Tarpeyo (budesonide)Calliditas Therapeutics AbODE-389 (orphan drug)215935
Dec 16, 2028Vybrique (sildenafil citrate)Ibsa Institut Biochimique SaNP (new product)210858
Dec 17, 2028Oxbryta (voxelotor)Global Blood Therapeutics IncODE-394 (orphan drug)213137
Dec 17, 2028Oxbryta (voxelotor)Global Blood Therapeutics IncODE-394 (orphan drug)216157
Dec 17, 2028Rubraca (rucaparib camsylate)Pharmaand GmbhI-982 (new indication)209115
Dec 18, 2028Filsuvez (birch triterpenes)Chiesi Farmaceutici SpaNCE (new chemical entity)215064
Dec 18, 2028Vraylar (cariprazine hydrochloride)Abbvie IncM-14 (miscellaneous)204370
Dec 18, 2028Vraylar (cariprazine hydrochloride)Abbvie IncNPP (new patient population)204370
Dec 19, 2028Accrufer (ferric maltol)Shield Tx Uk LtdNPP (new patient population)212320
Dec 19, 2028Jascayd (nerandomilast)Boehringer Ingelheim Pharmaceuticals IncI-979 (new indication)218764
Dec 19, 2028Mounjaro (autoinjector) (tirzepatide)Eli Lilly And CoNPP (new patient population)215866
Dec 21, 2028Wainua (autoinjector) (eplontersen sodium)Astrazeneca AbNCE (new chemical entity)217388
Dec 22, 2028Wegovy (semaglutide)Novo Nordisk IncNP (new product)218316
Dec 23, 2028Aqvesme (mitapivat sulfate)Agios Pharmaceuticals IncNP (new product)216196
Dec 30, 2028Recorlev (levoketoconazole)Strongbridge Dublin LtdODE-385 (orphan drug)214133

2029 · 141 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Jan 5, 2029Zelsuvmi (berdazimer sodium)Lnhc IncNCE (new chemical entity)217424
Jan 7, 2029Descovy (emtricitabine; tenofovir alafenamide fumarate)Gilead Sciences IncODE-554 (orphan drug)208215
Jan 16, 2029Nexplanon (etonogestrel)Organon Usa LlcD-199 (new dosing schedule)021529
Jan 21, 2029Verquvo (vericiguat)Merck Sharp And Dohme LlcD-198 (new dosing schedule)214377
Jan 27, 2029Noxafil (posaconazole)Merck Sharp And Dohme CorpNPP (new patient population)205053
Jan 27, 2029Noxafil (posaconazole)Merck Sharp And Dohme CorpNPP (new patient population)205596
Jan 27, 2029Noxafil Powdermix Kit (posaconazole)Merck Sharp And Dohme Corp A Sub Of MercI-984 (new indication)214770
Jan 28, 2029Yuvezzi (brimonidine tartrate; carbachol)Visus Therapeutics IncNP (new product)220142
Feb 12, 2029Leqvio (inclisiran sodium)Novartis Pharmaceuticals CorpI-985 (new indication)214012
Feb 12, 2029Leqvio (inclisiran sodium)Novartis Pharmaceuticals CorpNPP (new patient population)214012
Feb 13, 2029Rapiblyk (landiolol hydrochloride)Aop Health Us LlcNPP (new patient population)217202
Feb 17, 2029Pyrukynd (mitapivat sulfate)Agios Pharmaceuticals IncODE-392 (orphan drug)216196
Feb 19, 2029Calquence (acalabrutinib)Astrazeneca Uk LtdD-200 (new dosing schedule)210259
Feb 19, 2029Calquence (acalabrutinib maleate)Astrazeneca Uk LtdD-200 (new dosing schedule)216387
Feb 20, 2029Elucirem (gadopiclenol)GuerbetNPP (new patient population)216986
Feb 22, 2029Exblifep (cefepime hydrochloride; enmetazobactam)Orchid Pharma LtdNCE (new chemical entity)216165
Feb 24, 2029Braftovi (encorafenib)Array Biopharma IncI-997 (new indication)210496
Feb 25, 2029Juxtapid (lomitapide mesylate)Chiesi Farmaceutici SpaNPP (new patient population)203858
Feb 25, 2029Juxtapid (lomitapide mesylate)Chiesi Farmaceutici SpaNS (new strength)203858
Feb 28, 2029Vonjo (pacritinib citrate)Sobi IncODE-397 (orphan drug)208712
Mar 6, 2029Sotyktu (deucravacitinib)Bristol Myers Squibb CoI-986 (new indication)214958
Mar 14, 2029Rezdiffra (resmetirom)Madrigal Pharmaceuticals IncNCE (new chemical entity)217785
Mar 16, 2029Ibrance (palbociclib)Pfizer IncPED (pediatric)207103
Mar 16, 2029Ibrance (palbociclib)Pfizer IncPED (pediatric)212436
Mar 19, 2029Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncI-987 (new indication)213793
Mar 19, 2029Wegovy Hd (semaglutide)Novo Nordisk IncNS (new strength)215256
Mar 21, 2029Duvyzat (givinostat hydrochloride)Italfarmaco SpaNCE (new chemical entity)217865
Mar 22, 2029Hyftor (sirolimus)Nobelpharma Co LtdODE-391 (orphan drug)213478
Mar 22, 2029Jakafi (ruxolitinib phosphate)Incyte CorpPED (pediatric)202192
Mar 22, 2029Jakafi Xr (ruxolitinib phosphate)Incyte CorpPED (pediatric)217180
Mar 22, 2029Tryvio (aprocitentan)Idorsia Pharmaceuticals LtdNCE (new chemical entity)217686
Mar 23, 2029Tasigna (nilotinib hydrochloride)Novartis Pharmaceuticals CorpPED (pediatric)022068
Mar 25, 2029Fintepla (fenfluramine hydrochloride)Ucb IncODE-393 (orphan drug)212102
Mar 27, 2029Licart (diclofenac epolamine)Ibsa Institut Biochimique SaNPP (new patient population)206976
Mar 27, 2029Spinraza (nusinersen sodium)Biogen IncNS (new strength)209531
Mar 27, 2029Vafseo (vadadustat)Akebia Therapeutics IncNCE (new chemical entity)215192
Mar 29, 2029Voydeya (danicopan)Alexion Pharmaceuticals IncNCE (new chemical entity)218037
Apr 3, 2029Zevtera (ceftobiprole medocaril sodium)Istx LlcNCE (new chemical entity)218275
Apr 5, 2029Vijoice (alpelisib)Novartis Pharmaceuticals CorpODE-396 (orphan drug)215039
Apr 13, 2029Filspari (sparsentan)Travere Therapeutics IncI-989 (new indication)216403
Apr 17, 2029Lumisight (pegulicianine acetate)Lumicell IncNCE (new chemical entity)214511
Apr 23, 2029Ojemda (tovorafenib)Day One Biopharmaceuticals IncNCE (new chemical entity)217700
Apr 23, 2029Ojemda (tovorafenib)Day One Biopharmaceuticals IncNCE (new chemical entity)218033
Apr 24, 2029Caplyta (lumateperone tosylate)Intra-cellular Therapies IncM-319 (miscellaneous)209500
Apr 26, 2029Xolremdi (mavorixafor)X4 Pharmaceuticals IncNCE (new chemical entity)218709
Apr 27, 2029Breztri Aerosphere (budesonide; formoterol fumarate; glycopyrrolate)Astrazeneca AbNS (new strength)212122
Apr 27, 2029Nuplazid (pimavanserin tartrate)Acadia Pharmaceuticals IncM-14 (miscellaneous)207318
Apr 27, 2029Nuplazid (pimavanserin tartrate)Acadia Pharmaceuticals IncM-14 (miscellaneous)210793
Apr 27, 2029Symbicort Aerosphere (budesonide; formoterol fumarate)Astrazeneca Pharmaceuticals LpI-988 (new indication)216579
Apr 27, 2029Symbicort Aerosphere (budesonide; formoterol fumarate)Astrazeneca Pharmaceuticals LpNS (new strength)216579
Apr 28, 2029Camzyos (mavacamten)Bristol Myers Squibb CoODE-398 (orphan drug)214998
Apr 28, 2029Cuvrior (trientine tetrahydrochloride)Orphalan SaODE-401 (orphan drug)215760
Apr 30, 2029Auvelity (bupropion hydrochloride; dextromethorphan hydrobromide)Axsome Therapeutics IncI-913 (new indication)215430
May 4, 2029Linzess (linaclotide)Abbvie IncPED (pediatric)202811
May 12, 2029Radicava Ors (edaravone)Shionogi IncODE-144 (orphan drug)215446
May 12, 2029Zerbaxa (ceftolozane sulfate; tazobactam sodium)Cubist Pharmaceuticals LlcNPP (new patient population)206829
May 13, 2029Inqovi (cedazuridine; decitabine)Taiho Oncology IncI-990 (new indication)212576
May 13, 2029Nuzyra (omadacycline tosylate)Paratek Pharmaceuticals IncM-320 (miscellaneous)209816
May 13, 2029Nuzyra (omadacycline tosylate)Paratek Pharmaceuticals IncM-320 (miscellaneous)209817
May 14, 2029Trimbow (beclomethasone dipropionate; formoterol fumarate; glycopyrro)Chiesi Farmaceutici SpaNP (new product)219622
May 20, 2029Vidaza (azacitidine)Bristol-myers Squibb CoODE-399 (orphan drug)050794
May 21, 2029Linzess (linaclotide)Abbvie IncNPP (new patient population)202811
May 23, 2029Uptravi (selexipag)Actelion Pharmaceuticals Us IncNPP (new patient population)207947
May 23, 2029Uptravi (selexipag)Actelion Pharmaceuticals Us IncNS (new strength)207947
May 27, 2029Evrysdi (risdiplam)Genentech IncODE-400 (orphan drug)213535
Jun 1, 2029Ztalmy (ganaxolone)Immedica Pharma AbODE-395 (orphan drug)215904
Jun 10, 2029Iqirvo (elafibranor)Ipsen Biopharmaceuticals IncNCE (new chemical entity)218860
Jun 11, 2029Orladeyo (berotralstat dihydrochloride)Biocryst Pharmaceuticals IncPED (pediatric)219776
Jun 12, 2029Truqap (capivasertib)Astrazeneca Pharmaceuticals LpI-991 (new indication)218197
Jun 12, 2029Welireg (belzutifan)Merck Sharp And Dohme Corp A Sub Of MercI-994 (new indication)215383
Jun 13, 2029Amvuttra (vutrisiran sodium)Alnylam Pharmaceuticals IncODE-212 (orphan drug)215515
Jun 16, 2029Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncODE-402 (orphan drug)213793
Jun 18, 2029Vraylar (cariprazine hydrochloride)Abbvie IncPED (pediatric)204370
Jun 18, 2029Zegalogue (dasiglucagon hydrochloride)Zealand Pharma Us IncNPP (new patient population)214231
Jun 20, 2029Sofdra (sofpironium bromide)Botanix Sb IncNCE (new chemical entity)217347
Jun 24, 2029Ibrance (palbociclib)Pfizer IncI-995 (new indication)207103
Jun 24, 2029Ibrance (palbociclib)Pfizer IncI-995 (new indication)212436
Jun 24, 2029Tryngolza (autoinjector) (olezarsen sodium)Ionis Pharmaceuticals IncI-992 (new indication)218614
Jun 24, 2029Tryngolza (autoinjector) (olezarsen sodium)Ionis Pharmaceuticals IncNS (new strength)218614
Jun 26, 2029Ohtuvayre (ensifentrine)Merck Sharp And Dohme LlcNCE (new chemical entity)217389
Jun 29, 2029Zoryve (roflumilast)Arcutis Biotherapeutics IncNPP (new patient population)215985
Jul 1, 2029Kisqali (ribociclib succinate)Novartis Pharmaceuticals CorpM-14 (miscellaneous)209092
Jul 1, 2029Kisqali Femara Co-pack (copackaged) (letrozole; ribociclib succinate)Novartis Pharmaceuticals CorpM-14 (miscellaneous)209935
Jul 7, 2029Ryaltris (mometasone furoate; olopatadine hydrochloride)Glenmark Specialty SaNPP (new patient population)211746
Jul 14, 2029Diacomit (stiripentol)Biocodex SaODE-403 (orphan drug)206709
Jul 14, 2029Diacomit (stiripentol)Biocodex SaODE-403 (orphan drug)207223
Jul 14, 2029Xalkori (crizotinib)Pf Prism CvODE-407 (orphan drug)202570
Jul 16, 2029Recarbrio (cilastatin sodium; imipenem; relebactam)Merck Sharp And Dohme Corp A Sub Of MercGAIN (qualified infectious disease product (GAIN))212819
Jul 23, 2029Macrilen (macimorelin acetate)Aeterna Zentaris GmbhM-14 (miscellaneous)205598
Jul 24, 2029Tylenol With Naproxen (acetaminophen; naproxen sodium)Kenvue Brands LlcNP (new product)219962
Jul 25, 2029Leqselvi (deuruxolitinib phosphate)Sun Pharmaceutical Industries IncNCE (new chemical entity)217900
Jul 28, 2029Gwyn Lo (ethinyl estradiol; norelgestromin)Viatris Speciality LlcNP (new product)219990
Jul 31, 2029Pluvicto (lutetium lu-177 vipivotide tetraxetan)Novartis Pharmaceuticals CorpI-996 (new indication)215833
Aug 6, 2029Voranigo (vorasidenib)Servier Pharmaceuticals LlcNCE (new chemical entity)218784
Aug 9, 2029Yorvipath (palopegteriparatide)Ascendis Pharma Bone Diseases AsNCE (new chemical entity)216490
Aug 14, 2029Livdelzi (seladelpar lysine)Gilead Sciences IncNCE (new chemical entity)217899
Aug 14, 2029Pretomanid (pretomanid)Mylan Ireland LtdGAIN (qualified infectious disease product (GAIN))212862
Aug 19, 2029Lazcluze (lazertinib mesylate)Janssen Biotech IncNCE (new chemical entity)219008
Aug 19, 2029Xenleta (lefamulin acetate)Hong Kong King Friend Industrial Co LtdGAIN (qualified infectious disease product (GAIN))211673
Aug 19, 2029Xenleta (lefamulin acetate)Hong Kong King Friend Industrial Co LtdGAIN (qualified infectious disease product (GAIN))211672
Aug 24, 2029Imbruvica (ibrutinib)Pharmacyclics LlcODE-405 (orphan drug)205552
Aug 24, 2029Imbruvica (ibrutinib)Pharmacyclics LlcODE-405 (orphan drug)210563
Aug 24, 2029Imbruvica (ibrutinib)Pharmacyclics LlcODE-405 (orphan drug)217003
Aug 26, 2029Pemazyre (pemigatinib)Incyte CorpODE-404 (orphan drug)213736
Sep 2, 2029Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals IncODE-408 (orphan drug)211358
Sep 14, 2029Terlivaz (terlipressin acetate)Mallinckrodt Pharmaceuticals Ireland LtdODE-406 (orphan drug)022231
Sep 20, 2029Miplyffa (arimoclomol citrate)Zevra Denmark AsNCE (new chemical entity)214927
Sep 20, 2029Pedmark (sodium thiosulfate)Fennec Pharmaceuticals IncODE-384 (orphan drug)212937
Sep 21, 2029Retevmo (selpercatinib)Eli Lilly And CoODE-409 (orphan drug)213246
Sep 21, 2029Retevmo (selpercatinib)Eli Lilly And CoODE-412 (orphan drug)213246
Sep 21, 2029Retevmo (selpercatinib)Eli Lilly And CoODE* (orphan drug)218160
Sep 24, 2029Aqneursa (levacetylleucine)Intrabio IncNCE (new chemical entity)219132
Sep 25, 2029Fintepla (fenfluramine hydrochloride)Ucb IncPED (pediatric)212102
Sep 26, 2029Cobenfy (trospium chloride; xanomeline tartrate)Bristol-myers Squibb CoNCE (new chemical entity)216158
Sep 27, 2029Flyrcado (flurpiridaz f-18)Ge Healthcare IncNCE (new chemical entity)215168
Sep 29, 2029Firdapse (amifampridine phosphate)Catalyst Pharmaceuticals IncODE-553 (orphan drug)208078
Sep 29, 2029Relyvrio (sodium phenylbutyrate; taurursodiol)Amylyx Pharmaceuticals IncODE-411 (orphan drug)216660
Sep 30, 2029Lytgobi (futibatinib)Taiho Oncology IncODE-410 (orphan drug)214801
Sep 30, 2029Lytgobi (futibatinib)Taiho Oncology IncODE* (orphan drug)214801
Oct 6, 2029Oxlumo (lumasiran sodium)Alnylam Pharmaceuticals IncODE-415 (orphan drug)214103
Oct 10, 2029Itovebi (inavolisib)Genentech IncNCE (new chemical entity)219249
Oct 25, 2029Orlynvah (probenecid; sulopenem etzadroxil)Iterum Therapeutics Us LtdNCE (new chemical entity)213972
Oct 27, 2029Nuplazid (pimavanserin tartrate)Acadia Pharmaceuticals IncPED (pediatric)210793
Oct 27, 2029Nuplazid (pimavanserin tartrate)Acadia Pharmaceuticals IncPED (pediatric)207318
Oct 28, 2029Cotellic (cobimetinib fumarate)Genentech IncODE-416 (orphan drug)206192
Nov 12, 2029Zerbaxa (ceftolozane sulfate; tazobactam sodium)Cubist Pharmaceuticals LlcPED (pediatric)206829
Nov 14, 2029Fetroja (cefiderocol sulfate tosylate)Shionogi IncGAIN (qualified infectious disease product (GAIN))209445
Nov 15, 2029Revuforj (revumenib citrate)Syndax Pharmaceuticals IncNCE (new chemical entity)218944
Nov 17, 2029Sezaby (phenobarbital sodium)Sun Pharmaceutical Industries IncODE-414 (orphan drug)215910
Nov 22, 2029Attruby (acoramidis hydrochloride)Bridgebio Pharma IncNCE (new chemical entity)216540
Nov 22, 2029Rapiblyk (landiolol hydrochloride)Aop Health Us LlcNCE (new chemical entity)217202
Nov 23, 2029Uptravi (selexipag)Actelion Pharmaceuticals Us IncPED (pediatric)207947
Nov 27, 2029Iomervu (iomeprol)Bracco Diagnostics IncNCE (new chemical entity)216016
Nov 27, 2029Iomervu (iomeprol)Bracco Diagnostics IncNCE (new chemical entity)216017
Dec 1, 2029Rezlidhia (olutasidenib)Rigel Pharmaceuticals IncODE-413 (orphan drug)215814
Dec 7, 2029Xaciato (clindamycin phosphate)Organon LlcGAIN (qualified infectious disease product (GAIN))215650
Dec 12, 2029Krazati (adagrasib)Bristol Myers Squibb CoODE-352 (orphan drug)216340
Dec 13, 2029Crenessity (crinecerfont)Neurocrine Biosciences IncNCE (new chemical entity)218808
Dec 13, 2029Crenessity (crinecerfont)Neurocrine Biosciences IncNCE (new chemical entity)218820
Dec 18, 2029Ensacove (ensartinib hydrochloride)Xcovery Holdings IncNCE (new chemical entity)218171
Dec 20, 2029Alyftrek (deutivacaftor; tezacaftor; vanzacaftor calcium)Vertex Pharmaceuticals IncNCE (new chemical entity)218730

2030 · 106 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Jan 1, 2030Kisqali (ribociclib succinate)Novartis Pharmaceuticals CorpPED (pediatric)209092
Jan 1, 2030Kisqali Femara Co-pack (copackaged) (letrozole; ribociclib succinate)Novartis Pharmaceuticals CorpPED (pediatric)209935
Jan 19, 2030Brukinsa (zanubrutinib)Beone Medicines Usa IncODE-274 (orphan drug)213217
Jan 19, 2030Brukinsa (zanubrutinib)Beone Medicines Usa IncODE* (orphan drug)218785
Jan 19, 2030Tukysa (tucatinib)Seagen IncODE-422 (orphan drug)213411
Jan 21, 2030Grafapex (treosulfan)Medexus Pharma IncNCE (new chemical entity)214759
Jan 23, 2030Macrilen (macimorelin acetate)Aeterna Zentaris GmbhPED (pediatric)205598
Jan 27, 2030Jaypirca (pirtobrutinib)Loxo Oncology IncODE-424 (orphan drug)216059
Jan 30, 2030Journavx (suzetrigine)Vertex Pharmaceuticals IncNCE (new chemical entity)219209
Jan 31, 2030Revatio (sildenafil citrate)Viatris Specialty LlcODE-469 (orphan drug)021845
Feb 11, 2030Gomekli (mirdametinib)Springworks Therapeutics IncNCE (new chemical entity)219379
Feb 11, 2030Gomekli (mirdametinib)Springworks Therapeutics IncNCE (new chemical entity)219389
Feb 14, 2030Romvimza (vimseltinib)Deciphera Pharmaceuticals LlcNCE (new chemical entity)219304
Feb 17, 2030Filspari (sparsentan)Travere Therapeutics IncODE-389 (orphan drug)216403
Feb 24, 2030Imbruvica (ibrutinib)Pharmacyclics LlcPED (pediatric)217003
Feb 24, 2030Imbruvica (ibrutinib)Pharmacyclics LlcPED (pediatric)205552
Feb 24, 2030Imbruvica (ibrutinib)Pharmacyclics LlcPED (pediatric)210563
Feb 28, 2030Skyclarys (omaveloxolone)Biogen Us CorporationODE-427 (orphan drug)216718
Mar 2, 2030Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals IncPED (pediatric)211358
Mar 10, 2030Daybue (trofinetide)Acadia Pharmaceuticals IncODE-425 (orphan drug)217026
Mar 10, 2030Daybue Stix (trofinetide)Acadia Pharmaceuticals IncODE* (orphan drug)219884
Mar 13, 2030Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE-429 (orphan drug)214662
Mar 13, 2030Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE* (orphan drug)214662
Mar 16, 2030Mekinist (trametinib dimethyl sulfoxide)Novartis Pharmaceuticals CorpODE-428 (orphan drug)204114
Mar 16, 2030Mekinist (trametinib dimethyl sulfoxide)Novartis Pharmaceuticals CorpODE-428 (orphan drug)217513
Mar 16, 2030Tafinlar (dabrafenib mesylate)Novartis Pharmaceuticals CorpODE-428 (orphan drug)202806
Mar 16, 2030Tafinlar (dabrafenib mesylate)Novartis Pharmaceuticals CorpODE-428 (orphan drug)217514
Mar 21, 2030Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)213246
Mar 21, 2030Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)218160
Mar 22, 2030Rezzayo (rezafungin acetate)Mundipharma GmbhODE-426 (orphan drug)217417
Mar 24, 2030Joenja (leniolisib phosphate)Pharming Technologies BvODE-430 (orphan drug)217759
Mar 25, 2030Blujepa (gepotidacin mesylate)Glaxosmithkline LlcNCE (new chemical entity)218230
Mar 28, 2030Qfitlia (fitusiran sodium)Genzyme CorpNCE (new chemical entity)219019
Apr 2, 2030Vanrafia (atrasentan hydrochloride)Novartis Pharmaceuticals CorpNCE (new chemical entity)219208
Apr 25, 2030Qalsody (tofersen)Biogen Ma IncODE-432 (orphan drug)215887
Apr 26, 2030Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-433 (orphan drug)217660
May 1, 2030Lumryz (sodium oxybate)Alkermes IncODE-431 (orphan drug)214755
May 3, 2030Kalydeco (ivacaftor)Vertex Pharmaceuticals IncODE-435 (orphan drug)207925
May 8, 2030Avmapki Fakzynja Co-pack (copackaged) (avutometinib potassium; defactinib hydrochloride)Verastem IncNCE (new chemical entity)219616
May 22, 2030Ayvakit (avapritinib)Blueprint Medicines CorpODE-434 (orphan drug)212608
May 28, 2030Tryptyr (acoltremon)Alcon Laboratories IncNCE (new chemical entity)217370
Jun 5, 2030Prevymis (letermovir)Merck Sharp And Dohme CorpODE-423 (orphan drug)209939
Jun 5, 2030Prevymis (letermovir)Merck Sharp And Dohme CorpODE-423 (orphan drug)209940
Jun 5, 2030Prevymis (letermovir)Merck Sharp And Dohme LlcODE* (orphan drug)219104
Jun 11, 2030Ibtrozi (taletrectinib adipate)Nuvation Bio IncNCE (new chemical entity)219713
Jun 13, 2030Bylvay (odevixibat)Ipsen Biopharmaceuticals IncODE-436 (orphan drug)215498
Jul 2, 2030Zegfrovy (sunvozertinib)Dizal Pharmaceutical Co LtdNCE (new chemical entity)219839
Jul 3, 2030Ekterly (sebetralstat)Kalvista Pharmaceuticals LtdNCE (new chemical entity)219301
Jul 20, 2030Vanflyta (quizartinib dihydrochloride)Daiichi Sankyo IncODE-437 (orphan drug)216993
Jul 23, 2030Anzupgo (delgocitinib)Leo Pharma AsNCE (new chemical entity)219155
Jul 28, 2030Sephience (sepiapterin)Ptc Therapeutics IncNCE (new chemical entity)219666
Jul 31, 2030Vizz (aceclidine hydrochloride)Lenz Therapeutics IncNCE (new chemical entity)218585
Aug 6, 2030Modeyso (dordaviprone hydrochloride)Chimerix IncNCE (new chemical entity)219876
Aug 8, 2030Hernexeos (zongertinib)Boehringer Ingelheim Pharmaceuticals IncNCE (new chemical entity)219042
Aug 12, 2030Brinsupri (brensocatib)Insmed IncNCE (new chemical entity)217673
Aug 14, 2030Hepzato (melphalan hydrochloride)Delcath Systems IncODE-438 (orphan drug)201848
Aug 16, 2030Sohonos (palovarotene)Ipsen Biopharmaceuticals IncODE-439 (orphan drug)215559
Aug 18, 2030Ingrezza (valbenazine tosylate)Neurocrine Biosciences IncODE-440 (orphan drug)209241
Aug 29, 2030Wayrilz (rilzabrutinib)Genzyme CorpNCE (new chemical entity)219685
Sep 8, 2030Aphexda (motixafortide acetate)Ayrmid Pharma LtdODE-442 (orphan drug)217159
Sep 10, 2030Daybue (trofinetide)Acadia Pharmaceuticals IncPED (pediatric)217026
Sep 10, 2030Daybue Stix (trofinetide)Acadia Pharmaceuticals IncPED (pediatric)219884
Sep 15, 2030Ojjaara (momelotinib dihydrochloride)Glaxosmithkline LlcODE-441 (orphan drug)216873
Sep 16, 2030Mekinist (trametinib dimethyl sulfoxide)Novartis Pharmaceuticals CorpPED (pediatric)217513
Sep 16, 2030Mekinist (trametinib dimethyl sulfoxide)Novartis Pharmaceuticals CorpPED (pediatric)204114
Sep 16, 2030Tafinlar (dabrafenib mesylate)Novartis Pharmaceuticals CorpPED (pediatric)217514
Sep 16, 2030Tafinlar (dabrafenib mesylate)Novartis Pharmaceuticals CorpPED (pediatric)202806
Sep 19, 2030Forzinity (elamipretide hydrochloride)Stealth Biotherapeutics IncNCE (new chemical entity)215244
Sep 25, 2030Inluriyo (imlunestrant tosylate)Eli Lilly And CoNCE (new chemical entity)218881
Sep 25, 2030Palsonify (paltusotine hydrochloride)Crinetics Pharmaceuticals IncNCE (new chemical entity)219070
Sep 26, 2030Bosulif (bosutinib monohydrate)Pf Prism CvODE-444 (orphan drug)203341
Sep 26, 2030Bosulif (bosutinib monohydrate)Pf Prism CvODE-444 (orphan drug)217729
Sep 28, 2030Arikayce Kit (amikacin sulfate)Insmed IncGAIN (qualified infectious disease product (GAIN))207356
Sep 29, 2030Rivfloza (nedosiran sodium)Novo Nordisk IncODE-443 (orphan drug)215842
Sep 30, 2030Rhapsido (remibrutinib)Novartis Pharmaceuticals CorpNCE (new chemical entity)218436
Oct 7, 2030Jascayd (nerandomilast)Boehringer Ingelheim Pharmaceuticals IncNCE (new chemical entity)218764
Oct 11, 2030Braftovi (encorafenib)Array Biopharma IncODE-445 (orphan drug)210496
Oct 17, 2030Zilbrysq (zilucoplan sodium)Ucb IncODE-446 (orphan drug)216834
Oct 20, 2030Rozlytrek (entrectinib)Genentech IncODE-448 (orphan drug)212725
Oct 20, 2030Rozlytrek (entrectinib)Genentech IncODE-448 (orphan drug)218550
Oct 20, 2030Voxzogo (vosoritide)Biomarin Pharmaceutical IncODE-449 (orphan drug)214938
Oct 24, 2030Lynkuet (elinzanetant)Bayer Healthcare Pharmaceuticals IncNCE (new chemical entity)219469
Oct 24, 2030Tibsovo (ivosidenib)Servier Pharmaceuticals LlcODE-447 (orphan drug)211192
Oct 26, 2030Agamree (vamorolone)Catalyst Pharmaceuticals IncODE-450 (orphan drug)215239
Nov 3, 2030Kalydeco (ivacaftor)Vertex Pharmaceuticals IncPED (pediatric)207925
Nov 3, 2030Kygevvi (doxecitine; doxribtimine)Ucb IncNCE (new chemical entity)219792
Nov 13, 2030Komzifti (ziftomenib)Kura Oncology IncNCE (new chemical entity)220305
Nov 15, 2030Augtyro (repotrectinib)Bristol Myers Squibb CoODE-455 (orphan drug)218213
Nov 15, 2030Augtyro (repotrectinib)Bristol Myers Squibb CoODE* (orphan drug)218213
Nov 19, 2030Hyrnuo (sevabertinib)Bayer Healthcare Pharmaceuticals IncNCE (new chemical entity)219972
Nov 27, 2030Ogsiveo (nirogacestat hydrobromide)Springworks Therapeutics IncODE-452 (orphan drug)217677
Nov 27, 2030Ogsiveo (nirogacestat hydrobromide)Springworks Therapeutics IncODE* (orphan drug)217677
Dec 1, 2030Jaypirca (pirtobrutinib)Loxo Oncology IncODE-451 (orphan drug)216059
Dec 5, 2030Fabhalta (iptacopan hydrochloride)Novartis Pharmaceuticals CorpODE-456 (orphan drug)218276
Dec 8, 2030Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncODE-454 (orphan drug)207500
Dec 8, 2030Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncODE-458 (orphan drug)207500
Dec 8, 2030Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncODE-453 (orphan drug)207501
Dec 8, 2030Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncODE-459 (orphan drug)207501
Dec 12, 2030Cardamyst (etripamil)Milestone Pharmaceuticals Usa IncNCE (new chemical entity)218571
Dec 12, 2030Nuzolvence (zoliflodacin)Entasis Therapeutics IncNCE (new chemical entity)219491
Dec 13, 2030Iwilfin (eflornithine hydrochloride)Uswm LlcODE-462 (orphan drug)215500
Dec 18, 2030Filsuvez (birch triterpenes)Chiesi Farmaceutici SpaODE-460 (orphan drug)215064
Dec 19, 2030Myqorzo (aficamten)Cytokinetics IncNCE (new chemical entity)219083
Dec 20, 2030Tarpeyo (budesonide)Calliditas Therapeutics AbODE-464 (orphan drug)215935
Dec 21, 2030Wainua (autoinjector) (eplontersen sodium)Astrazeneca AbODE-461 (orphan drug)217388
Dec 30, 2030Nereus (tradipitant)Vanda Pharmaceuticals IncNCE (new chemical entity)220152

2031 · 88 exclusivities

EndsBrand (ingredient)ApplicantExclusivityNDA
Jan 12, 2031Zycubo (copper histidinate)Sentynl Therapeutics IncNCE (new chemical entity)211241
Feb 9, 2031Eohilia (budesonide)Takeda Pharmaceuticals Usa IncODE-466 (orphan drug)213976
Feb 12, 2031Adquey (difamilast)Acrotech Biopharma IncNCE (new chemical entity)219474
Feb 13, 2031Aurlumyn (iloprost)Btg International IncODE-465 (orphan drug)217933
Feb 13, 2031Onivyde (irinotecan hydrochloride)Ipsen Biopharmaceuticals IncODE-463 (orphan drug)207793
Feb 20, 2031Bysanti (milsaperidone)Vanda Pharmaceuticals IncNCE (new chemical entity)220358
Feb 23, 2031Biktarvy (bictegravir sodium; emtricitabine; tenofovir alafenamide fum)Gilead Sciences IncODE-468 (orphan drug)210251
Feb 27, 2031Yuviwel (navepegritide)Ascendis Pharma Growth Disorders AsNCE (new chemical entity)219164
Mar 7, 2031Brukinsa (zanubrutinib)Beone Medicines Usa IncODE-467 (orphan drug)213217
Mar 7, 2031Brukinsa (zanubrutinib)Beone Medicines Usa IncODE* (orphan drug)218785
Mar 13, 2031Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE-471 (orphan drug)214662
Mar 13, 2031Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE* (orphan drug)214662
Mar 17, 2031Icotyde (icotrokinra hydrochloride)Janssen Biotech IncNCE (new chemical entity)220149
Mar 17, 2031Lynavoy (linerixibat)Intercept Pharmaceuticals IncNCE (new chemical entity)220295
Mar 19, 2031Iclusig (ponatinib hydrochloride)Takeda Pharmaceuticals Usa IncODE-472 (orphan drug)203469
Mar 21, 2031Duvyzat (givinostat hydrochloride)Italfarmaco SpaODE-473 (orphan drug)217865
Mar 22, 2031Opsynvi (macitentan; tadalafil)Actelion Pharmaceuticals Us IncODE-475 (orphan drug)218490
Mar 25, 2031Lifyorli (copackaged) (relacorilant)Corcept Therapeutics IncNCE (new chemical entity)220641
Mar 26, 2031Bosulif (bosutinib monohydrate)Pf Prism CvPED (pediatric)217729
Mar 26, 2031Bosulif (bosutinib monohydrate)Pf Prism CvPED (pediatric)203341
Mar 29, 2031Voydeya (danicopan)Alexion Pharmaceuticals IncODE-476 (orphan drug)218037
Apr 1, 2031Foundayo (orforglipron calcium)Eli Lilly And CoNCE (new chemical entity)220934
Apr 4, 2031Xromi (hydroxyurea)Nova Laboratories LtdODE-470 (orphan drug)216593
Apr 18, 2031Alecensa (alectinib hydrochloride)Hoffmann-la Roche IncODE-477 (orphan drug)208434
Apr 20, 2031Idvynso (doravirine; islatravir)Merck Sharp And Dohme LlcNCE (new chemical entity)216964
Apr 23, 2031Lutathera (lutetium lu 177 dotatate)Advanced Accelerator Applications Usa InODE-479 (orphan drug)208700
Apr 23, 2031Ojemda (tovorafenib)Day One Biopharmaceuticals IncODE-478 (orphan drug)217700
Apr 23, 2031Ojemda (tovorafenib)Day One Biopharmaceuticals IncODE-478 (orphan drug)218033
Apr 26, 2031Rinvoq (upadacitinib)Abbvie IncODE-481 (orphan drug)211675
Apr 26, 2031Rinvoq Lq (upadacitinib)Abbvie IncODE-481 (orphan drug)218347
Apr 26, 2031Xolremdi (mavorixafor)X4 Pharmaceuticals IncODE-480 (orphan drug)218709
May 1, 2031Veppanu (vepdegestrant)Rigel Pharmaceuticals IncNCE (new chemical entity)219835
May 13, 2031Beqalzi (sonrotoclax)Beone Medicines Usa IncNCE (new chemical entity)220711
May 15, 2031Baxfendy (baxdrostat)Astrazeneca AbNCE (new chemical entity)219878
May 29, 2031Retevmo (selpercatinib)Eli Lilly And CoODE-484 (orphan drug)213246
May 29, 2031Retevmo (selpercatinib)Eli Lilly And CoODE-485 (orphan drug)213246
May 29, 2031Retevmo (selpercatinib)Eli Lilly And CoODE-487 (orphan drug)213246
May 29, 2031Retevmo (selpercatinib)Eli Lilly And CoODE* (orphan drug)218160
May 29, 2031Xocova (ensitrelvir)Shionogi IncNCE (new chemical entity)220442
May 29, 2031Zaynich (cefepime hydrochloride; zidebactam)Wockhardt Bio AgNCE (new chemical entity)220787
Jun 1, 2031Brexafemme (ibrexafungerp citrate)Glaxosmithkline LlcGAIN (qualified infectious disease product (GAIN))214900
Jun 6, 2031Rytelo (imetelstat sodium)Geron CorpODE-482 (orphan drug)217779
Jun 8, 2031Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncPED (pediatric)207501
Jun 8, 2031Cresemba (isavuconazonium sulfate)Astellas Pharma Us IncPED (pediatric)207500
Jun 10, 2031Iqirvo (elafibranor)Ipsen Biopharmaceuticals IncODE-486 (orphan drug)218860
Jun 12, 2031Ambelvist (gadoquatrane)Bayer Healthcare Pharmaceuticals IncNCE (new chemical entity)219627
Jun 13, 2031Augtyro (repotrectinib)Bristol Myers Squibb CoODE-483 (orphan drug)218213
Jun 17, 2031Utebzi (tebipenem pivoxil hydrobromide)Glaxosmithkline LlcNCE (new chemical entity)215960
Jun 21, 2031Wakix (pitolisant hydrochloride)Harmony Biosciences Management IncODE-489 (orphan drug)211150
Jul 14, 2031Revtorpyk (gedatolisib)Celcuity IncNCE (new chemical entity)219908
Jul 15, 2031Lipfendra (enlicitide decanoate)Merck Sharp And Dohme LlcNCE (new chemical entity)220848
Jul 22, 2031Jideytro (zidesamtinib)Nuvalent IncNCE (new chemical entity)220185
Jul 24, 2031Livmarli (maralixibat chloride)Mirum Pharmaceuticals IncODE-490 (orphan drug)214662
Aug 6, 2031Voranigo (vorasidenib)Servier Pharmaceuticals LlcODE-491 (orphan drug)218784
Aug 9, 2031Yorvipath (palopegteriparatide)Ascendis Pharma Bone Diseases AsODE-492 (orphan drug)216490
Aug 13, 2031Tauklarify (florquinitau f-18)Cerveau Technologies Inc A Lantheus CoNCE (new chemical entity)220496
Aug 13, 2031Zenbexus (iberdomide hydrochloride)Bristol Myers Squibb CoNCE (new chemical entity)221075
Aug 14, 2031Livdelzi (seladelpar lysine)Gilead Sciences IncODE-486 (orphan drug)217899
Aug 14, 2031Pretomanid (pretomanid)Mylan Ireland LtdGAIN (qualified infectious disease product (GAIN))212862
Aug 27, 2031Cypsedo (cipepofol)Haisco-usa Pharmaceuticals IncNCE (new chemical entity)220482
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme CorpODE-495 (orphan drug)209939
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme CorpODE-497 (orphan drug)209939
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme CorpODE-495 (orphan drug)209940
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme CorpODE-497 (orphan drug)209940
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme LlcODE-495 (orphan drug)219104
Aug 30, 2031Prevymis (letermovir)Merck Sharp And Dohme LlcODE-497 (orphan drug)219104
Sep 5, 2031Filspari (sparsentan)Travere Therapeutics IncODE-493 (orphan drug)216403
Sep 20, 2031Miplyffa (arimoclomol citrate)Zevra Denmark AsODE-496 (orphan drug)214927
Sep 22, 2031Opsynvi (macitentan; tadalafil)Actelion Pharmaceuticals Us IncPED (pediatric)218490
Sep 24, 2031Aqneursa (levacetylleucine)Intrabio IncODE-498 (orphan drug)219132
Oct 16, 2031Lumryz (sodium oxybate)Alkermes IncODE-494 (orphan drug)214755
Oct 23, 2031Lutathera (lutetium lu 177 dotatate)Advanced Accelerator Applications Usa InPED (pediatric)208700
Oct 29, 2031Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpODE-499 (orphan drug)215358
Oct 29, 2031Scemblix (asciminib hydrochloride)Novartis Pharmaceuticals CorpODE-500 (orphan drug)215358
Nov 15, 2031Revuforj (revumenib citrate)Syndax Pharmaceuticals IncODE-502 (orphan drug)218944
Nov 15, 2031Revuforj (revumenib citrate)Syndax Pharmaceuticals IncODE-504 (orphan drug)218944
Nov 15, 2031Revuforj (revumenib citrate)Syndax Pharmaceuticals IncODE-505 (orphan drug)218944
Nov 22, 2031Attruby (acoramidis hydrochloride)Bridgebio Pharma IncODE-506 (orphan drug)216540
Nov 29, 2031Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)213246
Nov 29, 2031Retevmo (selpercatinib)Eli Lilly And CoPED (pediatric)218160
Dec 13, 2031Crenessity (crinecerfont)Neurocrine Biosciences IncODE-503 (orphan drug)218808
Dec 13, 2031Crenessity (crinecerfont)Neurocrine Biosciences IncODE-503 (orphan drug)218820
Dec 19, 2031Tryngolza (autoinjector) (olezarsen sodium)Ionis Pharmaceuticals IncODE-515 (orphan drug)218614
Dec 20, 2031Alyftrek (deutivacaftor; tezacaftor; vanzacaftor calcium)Vertex Pharmaceuticals IncODE-526 (orphan drug)218730
Dec 20, 2031Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncODE-508 (orphan drug)213793
Dec 20, 2031Imcivree (setmelanotide acetate)Rhythm Pharmaceuticals IncODE-509 (orphan drug)213793
Dec 20, 2031Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-512 (orphan drug)212273
Dec 20, 2031Trikafta (copackaged) (elexacaftor, ivacaftor, tezacaftor; ivacaftor)Vertex Pharmaceuticals IncODE-512 (orphan drug)217660

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