2031 Patent Cliff

Updated August 16, 2026·next FDA decision on the calendar

102 drugs lose patent protection in 2031. The biggest single group is Cancer, with 15 drugs. Losing protection does not mean a drug disappears: it means other manufacturers can apply to sell the same medicine, and the original maker usually loses most of the sales within a year or two.

This is the earliest date a generic could enter; it is not a guarantee one will. We calculate it as the later of the last patent the company listed with the FDA and the last regulatory exclusivity. Companies often reach settlement agreements with generic makers for a different date, and those agreements are not public in this data.

Gilotrif (afatinib dimaleate)Boehringer Ingelheim · 30 patents · January 5, 2031

Besivance (besifloxacin hydrochloride)Bausch AND Lomb · 4 patents · January 9, 2031

Pliaglis (lidocaine; tetracaine)Crescita Therapeutics · 4 patents · January 14, 2031

Zypitamag (pitavastatin magnesium)Medicure International · 3 patents · January 19, 2031

Zusduri (mitomycin)Urogen Pharma · 4 patents · January 20, 2031

Jelmyto (mitomycin)Urogen Pharma · 3 patents · January 20, 2031

Dovato (dolutegravir sodium; lamivudine)Viiv Healthcare · 5 patents · January 24, 2031

Invega Sustenna (paliperidone palmitate)Janssen Pharmaceuticals · 10 patents · January 26, 2031

Uptravi (selexipag)Actelion Pharmaceuticals US · 8 patents · February 1, 2031

Vocabria (cabotegravir sodium)Viiv Healthcare · 2 patents · February 4, 2031

Lupron Depot (leuprolide acetate)Abbvie Endocrine · 2 patents · February 5, 2031

Lupron Depot-ped KIT (leuprolide acetate)Abbvie Endocrine · 2 patents · February 5, 2031

Teflaro (ceftaroline fosamil)Abbvie · 4 patents · February 10, 2031

Idose TR (travoprost)Glaukos · 4 patents · February 14, 2031

Quillivant XR (methylphenidate hydrochloride)Nextwave Pharmaceuticals · 7 patents · February 15, 2031

Apadaz (acetaminophen; benzhydrocodone hydrochlo)Zevra Therapeutics · 15 patents · February 22, 2031

Technegas KIT (technetium tc-99m labeled carbon)Cyclomedica Australia PTY · 1 patent · February 24, 2031

Edluar (zolpidem tartrate)Viatris Specialty · 4 patents · February 25, 2031

Xermelo (telotristat etiprate)Tersera Therapeutics · 5 patents · February 28, 2031

Relistor (methylnaltrexone bromide)Salix Pharmaceuticals · 9 patents · March 10, 2031

Bevespi Aerosphere (formoterol fumarate; glycopyrrolate)Astrazeneca Pharmaceuticals · 7 patents · March 17, 2031

Intrarosa (prasterone)Millicent Pharma · 3 patents · March 19, 2031

Xadago (safinamide mesylate)MDD US Operations · 6 patents · March 21, 2031

Gelnique (oxybutynin chloride)Abbvie · 3 patents · March 26, 2031

Bevyxxa (betrixaban)Portola Pharmaceuticals · 12 patents · March 29, 2031

Sodium Thiosulfate (sodium thiosulfate)Hope Pharmaceuticals · 6 patents · March 29, 2031

Bydureon Bcise (exenatide synthetic)Astrazeneca AB · 47 patents · April 4, 2031

Breo Ellipta (fluticasone furoate; vilanterol trifenat)Glaxo Group LTD England DBA Glaxos · 30 patents · April 11, 2031

Trelegy Ellipta (fluticasone furoate; umeclidinium bromid)Glaxosmithkline Intellectual Prope · 15 patents · April 11, 2031

Mekinist (trametinib dimethyl sulfoxide)Novartis Pharmaceuticals · 4 patents · April 15, 2031

Spiriva Respimat (tiotropium bromide)Boehringer Ingelheim Pharmaceutica · 4 patents · April 16, 2031

Treanda (bendamustine hydrochloride)Cephalon · 46 patents · April 26, 2031

Jevtana KIT (cabazitaxel)Sanofi Aventis US · 10 patents · April 27, 2031

Tegsedi (inotersen sodium)Akcea Therapeutics · 3 patents · April 29, 2031

Zepatier (elbasvir; grazoprevir)Merck Sharp AND Dohme · 2 patents · May 4, 2031

Ztlido (lidocaine)Scilex Pharmaceuticals · 8 patents · May 10, 2031

Xigduo XR (dapagliflozin; metformin hydrochloride)Astrazeneca AB · 50 patents · May 12, 2031

Qternmet XR (dapagliflozin; metformin hydrochloride; )Astrazeneca AB · 40 patents · May 12, 2031

Vesicare LS (solifenacin succinate)Astellas Pharma US · 1 patent · May 18, 2031

Naloxone Hydrochloride (autoinjector) (naloxone hydrochloride)Kaleo · 6 patents · May 24, 2031

Otrexup (methotrexate)Cosette Pharmaceuticals · 120 patents · May 27, 2031

Risvan (risperidone)Laboratorios Farmaceuticos Rovi · 28 patents · May 31, 2031

Seglentis (celecoxib; tramadol hydrochloride)Kowa Pharmaceuticals America · 7 patents · June 3, 2031

Cresemba (isavuconazonium sulfate)Astellas Pharma US · 12 patents · June 8, 2031

Cresemba (isavuconazonium sulfate)Astellas Pharma US · 2 patents · June 8, 2031

Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals · 94 patents · June 11, 2031

Orkambi (ivacaftor; lumacaftor)Vertex Pharmaceuticals · 126 patents · June 11, 2031

Sovaldi (sofosbuvir)Gilead Sciences · 34 patents · June 11, 2031

Sovaldi (sofosbuvir)Gilead Sciences · 32 patents · June 11, 2031

Mirvaso (brimonidine tartrate)Galderma Laboratories · 7 patents · June 13, 2031

Daklinza (daclatasvir dihydrochloride)Bristol-myers Squibb · 18 patents · June 13, 2031

Baxdela (delafloxacin meglumine)Melinta Subsidiary · 5 patents · June 19, 2031

Giazo (balsalazide disodium)Valeant Pharmaceuticals Internatio · 4 patents · June 23, 2031

Slynd (drospirenone)Exeltis USA · 15 patents · June 28, 2031

Drospirenone (drospirenone)Exeltis USA · 15 patents · June 28, 2031

Multaq (dronedarone hydrochloride)Sanofi Aventis US · 5 patents · June 30, 2031

Edarbyclor (azilsartan kamedoxomil; chlorthalidone)Azurity Pharmaceuticals · 6 patents · July 1, 2031

Iyuzeh (latanoprost)Thea Pharma · 1 patent · July 8, 2031

Mydcombi (phenylephrine hydrochloride; tropicamide)Eyenovia · 3 patents · July 15, 2031

Nerlynx (neratinib maleate)Puma Biotechnology · 20 patents · July 18, 2031

Tosymra (sumatriptan)Tonix Medicines · 9 patents · July 19, 2031

Pradaxa (dabigatran etexilate mesylate)Boehringer Ingelheim Pharmaceutica · 12 patents · July 20, 2031

Lynparza (olaparib)Astrazeneca Pharmaceuticals · 3 patents · August 4, 2031

Zilretta (triamcinolone acetonide)Pacira Pharmaceuticals · 2 patents · August 4, 2031

Thyquidity (levothyroxine sodium)Jerome Stevens Pharmaceuticals · 1 patent · August 6, 2031

Ecoza (econazole nitrate)Resilia Pharmaceuticals · 1 patent · August 8, 2031

Orenitram (treprostinil diolamine)United Therapeutics · 40 patents · August 11, 2031

Belrapzo (bendamustine hydrochloride)Eagle Pharmaceuticals · 20 patents · August 11, 2031

Eliquis (apixaban)Bristol Myers Squibb CO Pharmaceut · 25 patents · August 24, 2031

Prevymis (letermovir)Merck Sharp AND Dohme · 2 patents · August 30, 2031

Tpoxx (tecovirimat)Siga Technologies · 5 patents · September 4, 2031

Filspari (sparsentan)Travere Therapeutics · 8 patents · September 5, 2031

Uceris (budesonide)Salix Pharmaceuticals · 5 patents · September 7, 2031

Uloric (febuxostat)Takeda Pharmaceuticals USA · 4 patents · September 8, 2031

Nexiclon XR (clonidine)Rosemont Pharmaceuticals · 4 patents · September 8, 2031

Apretude (cabotegravir)Viiv Healthcare · 4 patents · September 15, 2031

Anzupgo (delgocitinib)LEO Pharma AS · 1 patent · September 19, 2031

Opsynvi (macitentan; tadalafil)Actelion Pharmaceuticals US · 12 patents · September 22, 2031

Verzenio (abemaciclib)ELI Lilly AND · 17 patents · September 28, 2031

Mulpleta (lusutrombopag)Vancocin Italia SRL · 3 patents · September 29, 2031

Cleviprex (clevidipine)Chiesi USA · 9 patents · October 10, 2031

Letairis (ambrisentan)Gilead Sciences · 6 patents · October 14, 2031

Talzenna (talazoparib tosylate)Pfizer · 34 patents · October 20, 2031

Talzenna (talazoparib tosylate)Pfizer · 36 patents · October 20, 2031

Qnasl (beclomethasone dipropionate)Teva Branded Pharmaceutical Produc · 2 patents · October 21, 2031

Angeliq (drospirenone; estradiol)Bayer Healthcare Pharmaceuticals · 1 patent · October 22, 2031

Mytesi (crofelemer)Napo Pharmaceuticals · 2 patents · October 31, 2031

Bryhali (halobetasol propionate)Bausch Health Americas · 6 patents · November 2, 2031

Solodyn (minocycline hydrochloride)Bausch Health US · 12 patents · November 17, 2031

Latuda (lurasidone hydrochloride)Sunovion Pharmaceuticals · 55 patents · November 23, 2031

Binosto (alendronate sodium)Radius Health · 1 patent · December 5, 2031

Keppra (levetiracetam)UCB · 8 patents · December 7, 2031

Enstilar (betamethasone dipropionate; calcipotrien)LEO Pharma AS · 11 patents · December 10, 2031

Segluromet (ertugliflozin; metformin hydrochloride)Merck Sharp AND Dohme · 12 patents · December 19, 2031

Steglatro (ertugliflozin)Merck Sharp AND Dohme · 2 patents · December 19, 2031

Steglujan (ertugliflozin; sitagliptin phosphate)Merck Sharp AND Dohme · 10 patents · December 19, 2031

Hysingla ER (hydrocodone bitartrate)Knoa Pharma · 133 patents · December 21, 2031

Pomalyst (pomalidomide)Bristol Myers Squibb · 24 patents · December 21, 2031

Nithiodote (sodium nitrite; sodium thiosulfate)Hope Pharmaceuticals · 9 patents · December 24, 2031

Sodium Nitrite (sodium nitrite)Hope Pharmaceuticals · 3 patents · December 24, 2031

Fanapt (iloperidone)Vanda Pharmaceuticals · 98 patents · December 28, 2031

Questions

How many drugs lose patent protection in 2031?

102 brand-name drugs lose patent protection in 2031, per the FDA Orange Book.

What is the largest therapeutic group in the 2031 patent cliff?

Cancer, with 15 drugs.

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Dates from the FDA Orange Book, the official record of which patents cover which approved drug; updated monthly. Facts only, not investment advice. Verify against the Orange Book and primary filings. pdufa.bio is not affiliated with the FDA.