pdufa.bio

2027 Patent Cliff

Updated ยทnext FDA decision on the calendar

64 drugs lose patent protection in 2027. The biggest single group is Metabolism & digestive, 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.
Vibativ (telavancin hydrochloride)Cumberland Pharmaceuticals · 2 patents · January 1, 2027
Striverdi Respimat (olodaterol hydrochloride)Boehringer Ingelheim Pharmaceutica · 1 patent · January 19, 2027
Kynamro (mipomersen sodium)Kastle Therapeutics · 1 patent · January 29, 2027
Nevanac (nepafenac)Harrow EYE · 1 patent · January 31, 2027
Ovide (malathion)Taro Pharmaceutical Industries · 2 patents · February 1, 2027
Lexiscan (regadenoson)Astellas Pharma US · 2 patents · February 2, 2027
Altabax (retapamulin)Almirall · 1 patent · February 14, 2027
Colazal (balsalazide disodium)Valeant Pharmaceuticals Internatio · 4 patents · February 24, 2027
Advil Allergy Sinus (chlorpheniramine maleate; ibuprofen; pse)Haleon US Holdings · 1 patent · February 28, 2027
Abilify (aripiprazole)Otsuka Pharmaceutical CO · 4 patents · March 2, 2027
Abilify (aripiprazole)Otsuka Pharmaceutical CO · 12 patents · March 2, 2027
Abilify (aripiprazole)Otsuka Pharmaceutical Development · 1 patent · March 2, 2027
Duavee (bazedoxifene acetate; estrogens, conjuga)Wyeth Pharmaceuticals · 2 patents · March 10, 2027
Veletri (epoprostenol sodium)Actelion Pharmaceuticals US · 4 patents · March 15, 2027
Dyloject (diclofenac sodium)Javelin Pharmaceuticals INC A Whol · 1 patent · March 22, 2027
Ximino (minocycline hydrochloride)Journey Medical · 9 patents · April 2, 2027
Oxtellar XR (oxcarbazepine)Supernus Pharmaceuticals · 33 patents · April 13, 2027
Chloraprep One-step (chlorhexidine gluconate; isopropyl alcoh)Becton Dickinson AND · 3 patents · April 25, 2027
Vitekta (elvitegravir)Gilead Sciences · 12 patents · April 26, 2027
Amyvid (florbetapir f-18)Avid Radiopharmaceuticals · 8 patents · April 30, 2027
Lyrica CR (pregabalin)Upjohn US 2 · 24 patents · May 2, 2027
Moxatag (amoxicillin)Pragma Pharmaceuticals · 3 patents · May 7, 2027
Rapivab (peramivir)Biocryst Pharmaceuticals · 5 patents · May 7, 2027
Aveed (testosterone undecanoate)Endo Operations · 2 patents · May 8, 2027
Janumet XR (metformin hydrochloride; sitagliptin pho)Merck Sharp AND Dohme · 6 patents · May 24, 2027
Januvia (sitagliptin phosphate)Merck Sharp AND Dohme · 6 patents · May 24, 2027
Balcoltra (ethinyl estradiol; levonorgestrel)Avion Pharmaceuticals · 1 patent · June 1, 2027
Corlanor (ivabradine hydrochloride)Amgen · 16 patents · June 12, 2027
Lumigan (bimatoprost)Abbvie · 1 patent · June 13, 2027
Prezista (darunavir)Janssen Products · 12 patents · June 26, 2027
Prezista (darunavir)Janssen Products · 2 patents · June 26, 2027
Antizol (fomepizole)PAR Pharmaceutical · 1 patent · June 30, 2027
Pristiq (desvenlafaxine succinate)PF Prism CV · 3 patents · July 5, 2027
Halaven (eribulin mesylate)Eisai · 2 patents · July 8, 2027
Epiduo (adapalene; benzoyl peroxide)Galderma Laboratories · 3 patents · July 18, 2027
Levitra (vardenafil hydrochloride)Bayer Healthcare Pharmaceuticals · 4 patents · July 23, 2027
Onsolis (fentanyl citrate)Adalvo · 5 patents · July 23, 2027
Rowasa (mesalamine)Mylan Specialty · 1 patent · July 24, 2027
Verdeso (desonide)Genus Lifesciences · 1 patent · August 13, 2027
Vistogard (uridine triacetate)BTG International · 1 patent · August 17, 2027
Fibricor (fenofibric acid)Rosemont Pharmaceuticals · 14 patents · August 20, 2027
Alsuma (sumatriptan succinate)Meridian Medical Technologies INC · 1 patent · August 26, 2027
Azilect (rasagiline mesylate)Teva Neuroscience · 4 patents · August 27, 2027
Argatroban IN Sodium Chloride (argatroban)Cipla · 2 patents · September 26, 2027
Emend (aprepitant)Merck Sharp AND Dohme · 6 patents · September 26, 2027
Emend (aprepitant)Merck Sharp AND Dohme · 1 patent · September 26, 2027
Axiron (testosterone)ELI Lilly AND · 6 patents · September 27, 2027
Chlorhexidine Gluconate (chlorhexidine gluconate)Sage Products · 2 patents · October 2, 2027
Byvalson (nebivolol hydrochloride; valsartan)Abbvie · 2 patents · October 4, 2027
Xyzal Allergy 24HR (levocetirizine dihydrochloride)Chattem INC DBA Sanofi Consumer He · 1 patent · October 16, 2027
Amitiza (lubiprostone)Sucampo Pharma Americas · 6 patents · October 25, 2027
Beleodaq (belinostat)Acrotech Biopharma · 2 patents · October 27, 2027
Elepsia XR (levetiracetam)Tripoint Therapeutics · 10 patents · October 31, 2027
Victrelis (boceprevir)Merck Sharp AND Dohme · 2 patents · November 11, 2027
Acular LS (ketorolac tromethamine)Abbvie · 2 patents · November 24, 2027
Toviaz (fesoterodine fumarate)Pfizer · 12 patents · December 7, 2027
Valcyte (valganciclovir hydrochloride)Cheplapharm Arzneimittel Gmbh · 2 patents · December 11, 2027
Troxyca ER (naltrexone hydrochloride; oxycodone hydr)Pfizer · 6 patents · December 12, 2027
Incruse Ellipta (umeclidinium bromide)Glaxo Group LTD England DBA Glaxos · 1 patent · December 18, 2027
Oracea (doxycycline)Galderma Laboratories · 1 patent · December 19, 2027
Zontivity (vorapaxar sulfate)KEY Therapeutics · 1 patent · December 23, 2027
Lastacaft (alcaftadine)Abbvie · 2 patents · December 23, 2027
Cardene (nicardipine hydrochloride)Chiesi USA · 22 patents · December 26, 2027
Tracleer (bosentan)Actelion Pharmaceuticals US · 2 patents · December 28, 2027

Questions

How many drugs lose patent protection in 2027?

64 brand-name drugs lose patent protection in 2027, per the FDA Orange Book.

What is the largest therapeutic group in the 2027 patent cliff?

Metabolism & digestive, with 9 drugs.

All years →