2028 Patent Cliff

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

80 drugs lose patent protection in 2028. The biggest single group is Respiratory, with 9 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.

Rayos (prednisone)Horizon Therapeutics USA · 4 patents · January 7, 2028

Atelvia (risedronate sodium)Allergan Pharmaceuticals Internati · 3 patents · January 9, 2028

Yutiq (fluocinolone acetonide)Alimera Sciences · 2 patents · January 12, 2028

Nayzilam (midazolam)UCB · 4 patents · January 18, 2028

Nourianz (istradefylline)Kyowa Kirin · 4 patents · January 28, 2028

Natazia (dienogest; estradiol valerate)Bayer Healthcare Pharmaceuticals · 2 patents · January 30, 2028

Dificid (fidaxomicin)Cubist Pharmaceuticals · 10 patents · January 31, 2028

Promacta (eltrombopag olamine)Novartis Pharmaceuticals · 79 patents · February 1, 2028

Omnaris (ciclesonide)Azurity Pharmaceuticals · 1 patent · February 1, 2028

Alvesco (ciclesonide)Azurity Pharmaceuticals · 2 patents · February 1, 2028

Zetonna (ciclesonide)Azurity Pharmaceuticals · 1 patent · February 1, 2028

Zometa (zoledronic acid)Novartis Pharmaceuticals · 1 patent · February 5, 2028

Perseris KIT (risperidone)Indivior · 20 patents · February 13, 2028

Injectafer (ferric carboxymaltose)American Regent · 90 patents · February 15, 2028

Revlimid (lenalidomide)Bristol Myers Squibb · 12 patents · March 8, 2028

Zolinza (vorinostat)Merck Sharp AND Dohme · 3 patents · March 18, 2028

Edarbi (azilsartan kamedoxomil)Azurity Pharmaceuticals · 2 patents · March 26, 2028

Savaysa (edoxaban tosylate)Daiichi Sankyo · 6 patents · March 28, 2028

Vusion (miconazole nitrate; white petrolatum; zi)Mylan Pharmaceuticals · 1 patent · March 30, 2028

Trokendi XR (topiramate)Supernus Pharmaceuticals · 80 patents · April 4, 2028

Macrilen (macimorelin acetate)Aeterna Zentaris Gmbh · 2 patents · April 12, 2028

Nicorette (nicotine polacrilex)Haleon US Holdings · 1 patent · April 30, 2028

Versacloz (clozapine)Douglas Pharmaceuticals America · 1 patent · May 1, 2028

Sorilux (calcipotriene)Mayne Pharma · 5 patents · May 7, 2028

Venlafaxine Besylate (venlafaxine besylate)Almatica Pharma · 1 patent · May 16, 2028

Dalvance (dalbavancin hydrochloride)Abbvie · 1 patent · May 23, 2028

Signifor LAR KIT (pasireotide pamoate)Recordati Rare Diseases · 15 patents · May 23, 2028

Incivek (telaprevir)Vertex Pharmaceuticals · 1 patent · May 30, 2028

Differin (adapalene)Galderma Laboratories · 3 patents · May 31, 2028

Doral (quazepam)Galt Pharmaceuticals · 2 patents · June 3, 2028

Astepro Allergy (azelastine hydrochloride)Bayer Healthcare Consumer Care · 2 patents · June 4, 2028

Astepro (azelastine hydrochloride)Viatris Specialty · 2 patents · June 4, 2028

Canasa (mesalamine)Abbvie · 2 patents · June 6, 2028

Duetact (glimepiride; pioglitazone hydrochloride)Takeda Pharmaceuticals USA · 4 patents · June 8, 2028

Bridion (sugammadex sodium)Merck Sharp AND Dohme · 4 patents · June 12, 2028

Farydak (panobinostat lactate)Secura BIO · 6 patents · June 13, 2028

Fentora (fentanyl citrate)Cephalon · 10 patents · June 15, 2028

Osmoprep (sodium phosphate, dibasic, anhydrous; so)Salix Pharmaceuticals · 1 patent · June 22, 2028

Vyondys 53 (golodirsen)Sarepta Therapeutics · 1 patent · June 28, 2028

Afinitor (everolimus)Novartis Pharmaceuticals · 12 patents · July 1, 2028

Yondelis (trabectedin)Janssen Products · 2 patents · July 7, 2028

Osphena (ospemifene)Duchesnay · 4 patents · July 9, 2028

Tekturna HCT (aliskiren hemifumarate; hydrochlorothiaz)Noden Pharma DAC · 4 patents · July 13, 2028

Tobradex ST (dexamethasone; tobramycin)Harrow EYE · 3 patents · August 3, 2028

Reclast (zoledronic acid)Sandoz · 2 patents · August 5, 2028

Syndros (dronabinol)Wellhouse Pharma · 4 patents · August 6, 2028

Caprelsa (vandetanib)Genzyme · 2 patents · August 8, 2028

Roxybond (oxycodone hydrochloride)Protega Pharmaceuticals · 8 patents · August 12, 2028

Morphabond ER (morphine sulfate)Ohemo Life Sciences · 8 patents · August 12, 2028

Xeljanz (tofacitinib citrate)PF Prism CV · 4 patents · August 21, 2028

Xeljanz (tofacitinib citrate)Pfizer · 2 patents · August 21, 2028

Forfivo XL (bupropion hydrochloride)TWI Pharmaceuticals · 1 patent · August 23, 2028

Twirla (ethinyl estradiol; levonorgestrel)Agile Therapeutics · 3 patents · August 26, 2028

Envarsus XR (tacrolimus)Veloxis Pharmaceuticals · 45 patents · August 30, 2028

Topicort (desoximetasone)SUN Pharma Canada · 2 patents · September 1, 2028

Nexavar (sorafenib tosylate)Bayer Healthcare Pharmaceuticals · 4 patents · September 10, 2028

Stiolto Respimat (olodaterol hydrochloride; tiotropium bro)Boehringer Ingelheim Pharmaceutica · 3 patents · September 13, 2028

Vizamyl (flutemetamol f-18)GE Healthcare · 2 patents · September 16, 2028

Keppra XR (levetiracetam)UCB · 2 patents · September 17, 2028

Bydureon (exenatide synthetic)Astrazeneca AB · 72 patents · September 21, 2028

Onmel (itraconazole)Sebela Ireland · 1 patent · October 3, 2028

Prepopik (citric acid; magnesium oxide; sodium pic)Ferring Pharmaceuticals · 2 patents · October 10, 2028

Flo-pred (prednisolone acetate)SUN Pharma Canada · 4 patents · October 11, 2028

Arcapta Neohaler (indacaterol maleate)Novartis Pharmaceuticals · 1 patent · October 11, 2028

Flonase Sensimist Allergy Relief (fluticasone furoate)Haleon US Holdings · 3 patents · October 15, 2028

Hemangeol (propranolol hydrochloride)Eton Pharmaceuticals · 2 patents · October 16, 2028

Utibron Neohaler (glycopyrrolate; indacaterol maleate)Novartis Pharmaceuticals · 2 patents · October 20, 2028

Seebri Neohaler (glycopyrrolate)Novartis Pharmaceuticals · 2 patents · October 20, 2028

Olux E (clobetasol propionate)Pharmobedient Consulting · 1 patent · November 5, 2028

Iluvien (fluocinolone acetonide)Alimera Sciences · 3 patents · November 7, 2028

Onglyza (saxagliptin hydrochloride)Astrazeneca AB · 2 patents · November 30, 2028

Loseasonique (ethinyl estradiol; levonorgestrel)Teva Branded Pharmaceutical Produc · 1 patent · December 5, 2028

Seasonique (ethinyl estradiol; levonorgestrel)Teva Branded Pharmaceutical Produc · 1 patent · December 5, 2028

Addyi (flibanserin)Sprout Pharmaceuticals · 1 patent · December 13, 2028

Suprax (cefixime)Lupin · 1 patent · December 14, 2028

Erivedge (vismodegib)Genentech · 2 patents · December 15, 2028

Remodulin (treprostinil)United Therapeutics · 4 patents · December 15, 2028

Staxyn (vardenafil hydrochloride)Bayer Healthcare Pharmaceuticals · 1 patent · December 23, 2028

Rytary (carbidopa; levodopa)Impax Laboratories · 60 patents · December 26, 2028

Questions

How many drugs lose patent protection in 2028?

80 brand-name drugs lose patent protection in 2028, per the FDA Orange Book.

What is the largest therapeutic group in the 2028 patent cliff?

Respiratory, with 9 drugs.

All years →

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.