FDA drug patent cliffs, 2026–2035
798 brand drugs lose their last patent or marketing-exclusivity protection over the next decade — the moment generics can enter. Every figure is computed live from official FDA Orange Book patent and exclusivity records.
798
brand cliffs 2026–2035
18
losing protection in 2026
1,385
brand applications still protected
Brand drugs losing protection, by year
Count of brand (NDA) applications whose latest Orange Book patent or exclusivity date falls in each year.
- 202618
- 202776
- 202894
- 202996
- 203080
- 2031104
- 203284
- 203388
- 203479
- 203579
Next protection expirations
The soonest brand cliffs ahead. Open any row for its full Orange Book record — listed patents, exclusivity periods, and the generics already referencing it.
| Drug | Applicant | Protection ends | Driver | Open record |
|---|---|---|---|---|
| DYMISTA AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE · NDA 202236 | MYLAN SPECIALITY LP | patent | ||
| SENSIPAR CINACALCET HYDROCHLORIDE · NDA 021688 | AMGEN | patent | ||
| SPRYCEL DASATINIB · NDA 021986 | BRISTOL MYERS SQUIBB | patent | ||
| VEREGEN SINECATECHINS · NDA 021902 | ANI PHARMS | patent | ||
| ARICEPT DONEPEZIL HYDROCHLORIDE · NDA 022568 | EISAI INC | patent | ||
| SAPHRIS ASENAPINE MALEATE · NDA 022117 | ABBVIE | patent | ||
| JUVISYNC SIMVASTATIN; SITAGLIPTIN PHOSPHATE · NDA 202343 | MERCK SHARP DOHME | patent | ||
| ANDROGEL TESTOSTERONE · NDA 022309 | BESINS HLTHCARE | patent | ||
| ADASUVE LOXAPINE · NDA 022549 | NOVA PNEUMA | patent | ||
| SYNRIBO OMACETAXINE MEPESUCCINATE · NDA 203585 | TEVA PHARMS INTL | patent | ||
| SUMAVEL DOSEPRO SUMATRIPTAN SUCCINATE · NDA 022239 | ENDO OPERATIONS | patent | ||
| NAROPIN ROPIVACAINE HYDROCHLORIDE · NDA 020533 | FRESENIUS KABI USA | patent | ||
| CLINDESSE CLINDAMYCIN PHOSPHATE · NDA 050793 | PADAGIS US | patent | ||
| PROTONIX PANTOPRAZOLE SODIUM · NDA 022020 | WYETH PHARMS | patent | ||
| CORLANOR IVABRADINE · NDA 209964 | AMGEN INC | patent | ||
| SIGNIFOR PASIREOTIDE DIASPARTATE · NDA 200677 | RECORDATI RARE | patent | ||
| VYNDAQEL TAFAMIDIS MEGLUMINE · NDA 211996 | FOLDRX PHARMS | patent | ||
| TISSUEBLUE BRILLIANT BLUE G · NDA 209569 | DUTCH OPHTHALMIC | exclusivity | ||
| VIBATIV TELAVANCIN HYDROCHLORIDE · NDA 022110 | CUMBERLAND | patent | ||
| NUCYNTA TAPENTADOL HYDROCHLORIDE · NDA 203794 | COLLEGIUM PHARM INC | exclusivity | ||
| NUCYNTA TAPENTADOL HYDROCHLORIDE · NDA 022304 | COLLEGIUM PHARM INC | exclusivity | ||
| PROVAYBLUE METHYLENE BLUE · NDA 204630 | PROVEPHARM SAS | exclusivity | ||
| STRIVERDI RESPIMAT OLODATEROL HYDROCHLORIDE · NDA 203108 | BOEHRINGER INGELHEIM | patent | ||
| KYNAMRO MIPOMERSEN SODIUM · NDA 203568 | KASTLE THERAPS LLC | patent | ||
| NEVANAC NEPAFENAC · NDA 021862 | HARROW EYE | patent | ||
| OVIDE MALATHION · NDA 018613 | TARO | patent | ||
| LEXISCAN REGADENOSON · NDA 022161 | ASTELLAS | patent | ||
| LEGUBETI ACETYLCYSTEINE LYSINE · NDA 215040 | GALEPHAR | exclusivity | ||
| ALTABAX RETAPAMULIN · NDA 022055 | ALMIRALL | patent | ||
| COLAZAL BALSALAZIDE DISODIUM · NDA 020610 | VALEANT PHARMS INTL | patent |
Methodology
A patent cliff is the year a brand product loses its last remaining protection — the latest of all its listed patent-expiry dates and marketing-exclusivity dates in the FDA Orange Book. We count brand (NDA) applications only; generics (ANDA) are the products that enter after a cliff, so they are excluded. Applications whose protection has already lapsed are not counted as upcoming.
Figures are computed directly from the official FDA Orange Book data file (snapshot 2026-07-29T23:43:54.069Z). Listed patents reflect those an NDA holder submits under 21 U.S.C. 355 and are not exhaustive; the actual date a generic can launch can also turn on Paragraph IV litigation and 180-day exclusivity. Free to reuse with attribution to Assyro.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
