Patent Cliff Calendar
Drugs losing US patent exclusivity in 2029
159 drugs face loss of exclusivity in 2029 · 136 small-molecule via Orange Book · 23 biologic via Purple Book BPCIA
What "patent cliff" means
When a drug's primary US patent expires, generic (small molecule) or biosimilar (biologic) competitors can apply to sell copies of that drug. The originator's revenue typically erodes by 30-50% within the first year of generic entry, and 60-80% within three years. For biologics, BPCIA 12-year reference product exclusivity acts as a parallel runway alongside patent protection.
2029 is a near-term cliff (3 years away). Biosimilar / generic filers are preparing IPR petitions and 351(k) / ANDA filings now.
Drugs losing exclusivity in 2029
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2029-06-04 | 72 patents | Formulation Method of Use Other |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2029-03-05 | 54 patents | Formulation Method of Use |
| Talzenna (Talazoparib Tosylate) | Pfizer Inc. | Small molecule | 2029-07-27 | 46 patents | Composition of Matter Method of Use |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2029-03-10 | 34 patents | Formulation Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2029-02-01 | 32 patents | Formulation Method of Use Other |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2029-01-28 | 28 patents | Formulation Method of Use Other |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2029-04-02 | 28 patents | Formulation Method of Use Other |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2029-03-26 | 22 patents | Composition of Matter Method of Use Other |
| oxymorphone-hydrochloride (OXYMORPHONE HYDROCHLORIDE) | — | Small molecule | 2029-07-10 | 21 patents | Composition of Matter |
| Invokana (CANAGLIFLOZIN) | Johnson & Johnson | Small molecule | 2029-02-26 | 20 patents | Method of Use Other |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2029-02-19 | 15 patents | Composition of Matter Other |
| Valium (diazepam) | Generic (originally Roche) | Small molecule | 2029-03-27 | 15 patents | Formulation |
| Xifaxan (rifaximin) | Bausch Health | Small molecule | 2029-02-26 | 15 patents | Method of Use |
| Lynparza (olaparib) | AstraZeneca | Small molecule | 2029-10-07 | 12 patents | Formulation |
| Monoferric (FERRIC DERISOMALTOSE) | Pharmacosmos | Small molecule | 2029-03-25 | 12 patents | Composition of Matter Method of Use |
| donepezil-hydrochloride (DONEPEZIL HYDROCHLORIDE) | — | Small molecule | 2029-03-24 | 12 patents | Method of Use Other |
| arimoclomol-citrate (ARIMOCLOMOL CITRATE) | — | Small molecule | 2029-06-26 | 12 patents | Method of Use |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2029-06-03 | 11 patents | Formulation Method of Use |
| Myrbetriq (MIRABEGRON) | Apgdi | Small molecule | 2029-04-30 | 10 patents | Formulation Method of Use Other |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2029-04-22 | 10 patents | Composition of Matter Other |
| Xalkori (crizotinib) | Pfizer | Small molecule | 2029-10-08 | 10 patents | Composition of Matter |
| Arthrotec (Diclofenac Sodium) | Pfizer | Small molecule | 2029-07-10 | 9 patents | Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2029-09-03 | 9 patents | Method of Use |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2029-08-12 | 9 patents | Method of Use |
| tenapanor-hydrochloride (TENAPANOR HYDROCHLORIDE) | — | Small molecule | 2029-12-30 | 9 patents | Composition of Matter Method of Use |
| viloxazine-hydrochloride (VILOXAZINE HYDROCHLORIDE) | — | Small molecule | 2029-09-04 | 9 patents | Method of Use |
| Advil (ibuprofen) | Generic (originally Boots Group) | Small molecule | 2029-09-30 | 8 patents | Method of Use |
| Onpattro (PATISIRAN SODIUM) | Alnylam Pharmaceuticals | Small molecule | 2029-04-15 | 8 patents | Formulation Method of Use |
| Remodulin (TREPROSTINIL) | United Therap | Small molecule | 2029-03-29 | 8 patents | Method of Use |
| Subutex (Buprenorphine Hydrochloride) | Indivior | Small molecule | 2029-08-07 | 8 patents | Method of Use |
| memantine-hydrochloride (MEMANTINE HYDROCHLORIDE) | — | Small molecule | 2029-03-24 | 8 patents | Method of Use Other |
| Aldara (IMIQUIMOD) | Bausch Health | Small molecule | 2029-08-18 | 7 patents | Method of Use |
| Opsumit (MACITENTAN) | AstraZeneca | Small molecule | 2029-04-04 | 7 patents | Method of Use Other |
| Piqray (alpelisib) | Novartis | Small molecule | 2029-09-10 | 7 patents | Composition of Matter |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2029-03-11 | 7 patents | Formulation Method of Use Other |
| ferric-oxyhydroxide (FERRIC OXYHYDROXIDE) | — | Small molecule | 2029-05-13 | 7 patents | Other |
| Aloprim (ALLOPURINOL) | Casper Pharma Llc | Small molecule | 2029-04-29 | 6 patents | Method of Use |
| Arnuity Ellipta (FLUTICASONE FUROATE) | Haleon Us Holdings | Small molecule | 2029-02-26 | 6 patents | Method of Use Other |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2029-01-08 | 6 patents | Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2029-02-10 | 6 patents | Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2029-04-10 | 6 patents | Formulation |
| Jadelle (LEVONORGESTREL) | Fdn Consumer | Small molecule | 2029-09-14 | 6 patents | Method of Use |
| Lamictal (lamotrigine) | GSK | Small molecule | 2029-01-07 | 6 patents | Formulation |
| Prevymis (LETERMOVIR) | Merck & Co. | Small molecule | 2029-01-18 | 6 patents | Composition of Matter |
| Rexulti (BREXPIPRAZOLE) | Otsuka | Small molecule | 2029-06-23 | 6 patents | Other |
| afatinib-dimaleate (AFATINIB DIMALEATE) | — | Small molecule | 2029-10-10 | 6 patents | Composition of Matter Formulation |
| chembl-chembl2103744 (MORPHINE SULFATE) | — | Small molecule | 2029-11-07 | 6 patents | Method of Use |
| Nuzyra (OMADACYCLINE TOSYLATE) | Paratek Pharms | Small molecule | 2029-03-05 | 5 patents | Formulation Method of Use |
| Reglan (Metoclopramide Hydrochloride) | Hikma | Small molecule | 2029-12-22 | 5 patents | Method of Use |
| Skyclarys (OMAVELOXOLONE) | Biogen Us | Small molecule | 2029-04-20 | 5 patents | Composition of Matter Formulation Method of Use |
| Travatan (TRAVOPROST) | — | Small molecule | 2029-03-13 | 5 patents | Formulation |
| Zulresso (BREXANOLONE) | Sage Therap | Small molecule | 2029-03-13 | 5 patents | Formulation |
| Cipro (Ciprofloxacin) | Alk Abello | Small molecule | 2029-04-21 | 4 patents | Formulation Method of Use |
| Differin (ADAPALENE) | Galderma Labs Lp | Small molecule | 2029-06-03 | 4 patents | Method of Use |
| Tudorza Pressair (ACLIDINIUM BROMIDE) | Covis | Small molecule | 2029-03-13 | 4 patents | Method of Use |
| Vidaza (azacitidine) | Bristol-Myers Squibb | Small molecule | 2029-05-14 | 4 patents | Formulation Method of Use |
| metformin-hydrochloride (METFORMIN HYDROCHLORIDE) | — | Small molecule | 2029-01-21 | 4 patents | Formulation Other |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2029-04-10 | 4 patents | Formulation |
| Agamree (VAMOROLONE) | Catalyst Pharms | Small molecule | 2029-05-28 | 3 patents | Formulation Method of Use |
| Alphagan (BRIMONIDINE TARTRATE) | Senju Pharmaceutical Co., Ltd | Small molecule | 2029-07-27 | 3 patents | Method of Use |
| Alunbrig (brigatinib) | Takeda | Small molecule | 2029-05-21 | 3 patents | Method of Use |
| Caduet (Amlodipine Besylate) | Pfizer Inc. | Small molecule | 2029-10-05 | 3 patents | Method of Use |
| Kyprolis (carfilzomib) | Amgen | Small molecule | 2029-10-21 | 3 patents | Method of Use |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2029-05-07 | 3 patents | Formulation Method of Use |
| Tegretol (carbamazepine) | Novartis AG (originally Geigy) | Small molecule | 2029-03-13 | 3 patents | Formulation |
| Triferic (FERRIC PYROPHOSPHATE CITRATE) | Rockwell Medical Inc | Small molecule | 2029-04-17 | 3 patents | Method of Use |
| Xiidra (LIFITEGRAST) | Bausch Health | Small molecule | 2029-04-15 | 3 patents | Method of Use |
| Zurampic (LESINURAD) | Ironwood Pharms Inc | Small molecule | 2029-04-29 | 3 patents | Method of Use |
| nilotinib-hydrochloride (Nilotinib Hydrochloride) | Jan Beumer | Small molecule | 2029-02-23 | 3 patents | Other |
| diazoxide-choline (DIAZOXIDE CHOLINE) | — | Small molecule | 2029-03-05 | 3 patents | Composition of Matter |
| posaconazole (POSACONAZOLE) | — | Small molecule | 2029-03-13 | 3 patents | Formulation |
| Angiomax (BIVALIRUDIN) | Novartis | Small molecule | 2029-01-27 | 2 patents | Other |
| Braftovi (encorafenib) | Pfizer | Small molecule | 2029-07-23 | 2 patents | Composition of Matter |
| Copiktra (DUVELISIB) | Secura | Small molecule | 2029-01-05 | 2 patents | Method of Use |
| Cytarabine (Cytarabine) | Nippon Shinyaku Co., Ltd. | Small molecule | 2029-04-01 | 2 patents | Method of Use Other |
| Daurismo (Glasdegib Maleate) | Pfizer | Small molecule | 2029-04-14 | 2 patents | Composition of Matter |
| Endometrin (progesterone) | Ferring | Small molecule | 2029-02-03 | 2 patents | Formulation Method of Use |
| Epivir (LAMIVUDINE) | GSK | Small molecule | 2029-03-11 | 2 patents | Method of Use Other |
| Eucrisa (Crisaborole) | Anacor Pharms Inc | Small molecule | 2029-06-29 | 2 patents | Composition of Matter Other |
| Exondys 51 (ETEPLIRSEN) | Sarepta | Small molecule | 2029-02-02 | 2 patents | Formulation |
| Ferriprox (DEFERIPRONE) | Chiesi | Small molecule | 2029-10-26 | 2 patents | Method of Use |
| Horizant (GABAPENTIN ENACARBIL) | Azurity | Small molecule | 2029-06-10 | 2 patents | Method of Use |
| Jascayd (NERANDOMILAST) | Boehringer Ingelheim | Small molecule | 2029-11-26 | 2 patents | Method of Use |
| Mitozytrex (MITOMYCIN) | Kyowa Kirin Co., Ltd. | Small molecule | 2029-02-01 | 2 patents | Formulation Method of Use |
| Olumiant (baricitinib) | Eli Lilly | Small molecule | 2029-03-10 | 2 patents | Method of Use |
| Spy Agent Green Kit (INDOCYANINE GREEN) | Renew Pharms | Small molecule | 2029-02-11 | 2 patents | Method of Use |
| Viberzi (ELUXADOLINE) | AbbVie | Small molecule | 2029-05-27 | 2 patents | Composition of Matter |
| Xerava (ERAVACYCLINE DIHYDROCHLORIDE) | Tetraphase Pharms | Small molecule | 2029-08-07 | 2 patents | Method of Use |
| Zofran (ondansetron) | GSK (originally Glaxo) | Small molecule | 2029-11-23 | 2 patents | Formulation |
| Zokinvy (LONAFARNIB) | Sentynl Theraps Inc | Small molecule | 2029-07-26 | 2 patents | Method of Use |
| abacavir-sulfate (ABACAVIR SULFATE) | — | Small molecule | 2029-12-08 | 2 patents | Composition of Matter |
| capmatinib-hydrochloride (CAPMATINIB HYDROCHLORIDE) | — | Small molecule | 2029-05-20 | 2 patents | Method of Use |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2029-08-20 | 2 patents | Method of Use |
| doxepin-hydrochloride (DOXEPIN HYDROCHLORIDE) | — | Small molecule | 2029-06-01 | 2 patents | Formulation |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2029-03-13 | 2 patents | Formulation |
| moxifloxacin-hydrochloride (MOXIFLOXACIN HYDROCHLORIDE) | — | Small molecule | 2029-05-29 | 2 patents | Formulation |
| oxybutynin-chloride (OXYBUTYNIN CHLORIDE) | — | Small molecule | 2029-11-06 | 2 patents | Method of Use |
| Amondys 45 (CASIMERSEN) | Sarepta | Small molecule | 2029-02-16 | 1 patents | Method of Use |
| Azelex (AZELAIC ACID) | Leo Pharma As | Small molecule | 2029-02-28 | 1 patents | Method of Use |
| Brenzavvy (BEXAGLIFLOZIN) | Theracosbio | Small molecule | 2029-01-30 | 1 patents | Method of Use |
| Bupivacaine Hydrochloride And Epinephrine (Bupivacaine Hydrochloride) | Pfizer | Small molecule | 2029-05-20 | 1 patents | Method of Use |
| Col-Probenecid (probenecid) | Pfizer Inc. | Small molecule | 2029-06-03 | 1 patents | Method of Use |
| Dexilant (DEXLANSOPRAZOLE) | Takeda | Small molecule | 2029-03-10 | 1 patents | Formulation |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2029-01-28 | 1 patents | Composition of Matter |
| Inbrija (LEVODOPA) | Merz | Small molecule | 2029-02-03 | 1 patents | Method of Use |
| Kengreal (CANGRELOR) | Chiesi | Small molecule | 2029-05-13 | 1 patents | Method of Use |
| Klisyri (TIRBANIBULIN) | Almirall | Small molecule | 2029-02-02 | 1 patents | Method of Use |
| Lignospan Forte (Lidocaine Hydrochloride) | Fresenius Kabi | Small molecule | 2029-10-22 | 1 patents | Method of Use |
| Lumigan (BIMATOPROST) | — | Small molecule | 2029-04-24 | 1 patents | Formulation |
| Orgovyx (relugolix) | MYOVANT SCIENCES | Small molecule | 2029-01-28 | 1 patents | Composition of Matter |
| Rapamune (sirolimus) | Pfizer | Small molecule | 2029-02-14 | 1 patents | Method of Use |
| Rilutek (RILUZOLE) | Covis | Small molecule | 2029-03-12 | 1 patents | Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2029-06-02 | 1 patents | Formulation |
| Sustiva (EFAVIRENZ) | Bristol-Myers Squibb | Small molecule | 2029-04-28 | 1 patents | Formulation |
| Tryvio (APROCITENTAN) | Idorsia | Small molecule | 2029-09-21 | 1 patents | Method of Use |
| Tygacil (TIGECYCLINE) | Fresenius Kabi | Small molecule | 2029-02-05 | 1 patents | Formulation |
| Velsipity (Etrasimod Arginine) | Pfizer Inc. | Small molecule | 2029-07-22 | 1 patents | Method of Use |
| Viramune (NEVIRAPINE) | Boehringer Ingelheim | Small molecule | 2029-03-12 | 1 patents | Method of Use |
| Vyzulta (LATANOPROSTENE BUNOD) | Bausch Health | Small molecule | 2029-02-21 | 1 patents | Method of Use |
| Winlevi (CLASCOTERONE) | Sun Pharma | Small molecule | 2029-02-28 | 1 patents | Formulation |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2029-09-12 | 1 patents | Formulation |
| Zelboraf (vemurafenib) | Hoffmann La Roche | Small molecule | 2029-06-20 | 1 patents | Composition of Matter |
| Zepatier (ELBASVIR) | Merck & Co. | Small molecule | 2029-07-24 | 1 patents | Method of Use |
| Zepzelca (LURBINECTEDIN) | Jazz Pharmaceuticals | Small molecule | 2029-12-13 | 1 patents | Method of Use |
| bromfenac-sodium (BROMFENAC SODIUM) | — | Small molecule | 2029-03-05 | 1 patents | Method of Use |
| zoliflodacin (ZOLIFLODACIN) | — | Small molecule | 2029-10-13 | 1 patents | Method of Use |
| fostemsavir-tromethamine (FOSTEMSAVIR TROMETHAMINE) | — | Small molecule | 2029-07-13 | 1 patents | Formulation |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2029-02-26 | 1 patents | Method of Use |
| nitroglycerin (NITROGLYCERIN) | — | Small molecule | 2029-03-12 | 1 patents | Method of Use |
| isopropyl-alcohol (ISOPROPYL ALCOHOL) | — | Small molecule | 2029-08-09 | 1 patents | Method of Use |
| fosdenopterin-hydrobromide (FOSDENOPTERIN HYDROBROMIDE) | — | Small molecule | 2029-04-09 | 1 patents | Method of Use |
| neratinib-maleate (NERATINIB MALEATE) | — | Small molecule | 2029-08-04 | 1 patents | Method of Use |
| naltrexone (NALTREXONE) | — | Small molecule | 2029-10-15 | 1 patents | Method of Use |
| triheptanoin (TRIHEPTANOIN) | — | Small molecule | 2029-04-28 | 1 patents | Formulation |
| atazanavir-sulfate (ATAZANAVIR SULFATE) | — | Small molecule | 2029-09-03 | 1 patents | Method of Use |
| vibegron (VIBEGRON) | — | Small molecule | 2029-04-02 | 1 patents | Composition of Matter |
| ADALIMUMAB-ADBM (ADALIMUMAB-ADBM) | BOEHRINGER INGELHEIM | Biologic | 2029-08-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ADMELOG (INSULIN LISPRO) | Eli Lilly | Biologic | 2029-12-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BAVENCIO (avelumab) | Merck KGaA | Biologic | 2029-03-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BENLYSTA (BELIMUMAB) | Human Genome Sciences Inc. | Biologic | 2029-07-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BESPONSA (INOTUZUMAB OZOGAMICIN) | WYETH PHARMS INC | Biologic | 2029-08-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BRINEURA (CERLIPONASE ALFA) | BioMarin | Biologic | 2029-04-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Dupixent (DUPILUMAB) | Regeneron | Biologic | 2029-03-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| FASENRA (BENRALIZUMAB) | AstraZeneca | Biologic | 2029-11-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| FIASP | NOVO | Biologic | 2029-09-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| HEMLIBRA (EMICIZUMAB) | Roche | Biologic | 2029-11-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Imfinzi (durvalumab) | AstraZeneca | Biologic | 2029-05-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| KEVZARA (SARILUMAB) | SANOFI SYNTHELABO | Biologic | 2029-05-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MEPSEVII (VESTRONIDASE ALFA) | Ultragenyx Pharm Inc | Biologic | 2029-11-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MVASI (Bevacizumab-awwb) | Amgen | Biologic | 2029-09-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MYLOTARG (GEMTUZUMAB) | Wyeth Pharms Inc | Biologic | 2029-09-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OGIVRI (TRASTUZUMAB-DKST) | MYLAN GMBH | Biologic | 2029-12-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Ocrevus (OCRELIZUMAB) | Roche | Biologic | 2029-03-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RENFLEXIS (infliximab) | Johnson & Johnson | Biologic | 2029-04-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RITUXAN HYCELA | GENENTECH INC | Biologic | 2029-06-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SILIQ (BRODALUMAB) | Valeant Luxembourg | Biologic | 2029-02-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Tremfya (GUSELKUMAB) | Johnson & Johnson | Biologic | 2029-07-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | PFIZER INC | Biologic | 2029-12-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | EMD SERONO INC | Biologic | 2029-05-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
Sources
- FDA Orange Book — patents listed against approved small-molecule drugs (NDAs).
- FDA Purple Book — BPCIA 12-year reference product exclusivity for licensed biologics (BLAs).
- USPTO PatentsView + Google Patents — title, abstract, and claim text grounding.
- Drug Landscape — AI-augmented enrichment and consolidated estate analysis.
Data shown is sourced from public regulatory and patent databases as of 2026-05-17. Patent term extensions, supplementary protection certificates, pediatric exclusivity, and pending IPR challenges may shift the effective expiry date. Not legal advice.