Patent Cliff Calendar
Drugs losing US patent exclusivity in 2037
105 drugs face loss of exclusivity in 2037 · 64 small-molecule via Orange Book · 41 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.
2037 is long-dated (11 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2037
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Daliresp (ROFLUMILAST) | Arcutis | Small molecule | 2037-06-07 | 65 patents | Formulation Method of Use |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2037-02-28 | 30 patents | Formulation |
| Sohonos (PALOVAROTENE) | Ipsen | Small molecule | 2037-06-08 | 25 patents | Method of Use |
| cocaine-hydrochloride (COCAINE HYDROCHLORIDE) | — | Small molecule | 2037-02-07 | 23 patents | Formulation Method of Use |
| Yorvipath (PALOPEGTERIPARATIDE) | Ascendis Pharma Bone | Small molecule | 2037-09-28 | 21 patents | Composition of Matter Formulation Method of Use |
| Retevmo (SELPERCATINIB) | Eli Lilly | Small molecule | 2037-10-10 | 18 patents | Composition of Matter Method of Use |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2037-06-01 | 16 patents | Other |
| cysteamine-bitartrate (CYSTEAMINE BITARTRATE) | — | Small molecule | 2037-02-16 | 16 patents | Other |
| perflutren (PERFLUTREN) | — | Small molecule | 2037-03-16 | 16 patents | Method of Use |
| Amphetamine Sulfate (AMPHETAMINE SULFATE) | Azurity | Small molecule | 2037-03-10 | 14 patents | Formulation Method of Use |
| donepezil-hydrochloride (DONEPEZIL HYDROCHLORIDE) | — | Small molecule | 2037-05-26 | 14 patents | Formulation Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2037-06-08 | 12 patents | Method of Use Other |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2037-06-08 | 12 patents | Method of Use Other |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2037-08-09 | 12 patents | Composition of Matter Method of Use |
| amlodipine-benzoate (AMLODIPINE BENZOATE) | — | Small molecule | 2037-10-06 | 12 patents | Formulation Method of Use |
| Brukinsa (ZANUBRUTINIB) | BeiGene | Small molecule | 2037-08-15 | 10 patents | Composition of Matter Method of Use |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2037-09-05 | 10 patents | Formulation Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2037-04-28 | 9 patents | Method of Use |
| Calcium Gluconate (CALCIUM GLUCONATE) | — | Small molecule | 2037-07-25 | 8 patents | Formulation |
| Iqirvo (ELAFIBRANOR) | Ipsen | Small molecule | 2037-03-30 | 8 patents | Method of Use |
| Piqray (alpelisib) | Novartis | Small molecule | 2037-02-17 | 8 patents | Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2037-12-21 | 6 patents | Method of Use |
| Orgovyx (relugolix) | MYOVANT SCIENCES | Small molecule | 2037-09-29 | 6 patents | Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2037-03-16 | 6 patents | Other |
| Zurzuvae (ZURANOLONE) | Biogen | Small molecule | 2037-08-23 | 6 patents | Composition of Matter Method of Use |
| fosnetupitant-chloride-hydrochloride (FOSNETUPITANT CHLORIDE HYDROCHLORIDE) | — | Small molecule | 2037-06-02 | 6 patents | Formulation |
| Lipitor (Atorvastatin Calcium) | Pfizer | Small molecule | 2037-06-07 | 5 patents | Formulation Method of Use |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2037-01-18 | 5 patents | Method of Use |
| Nuzyra (OMADACYCLINE TOSYLATE) | Paratek Pharms | Small molecule | 2037-08-03 | 5 patents | Method of Use |
| Inlyta (Axitinib) | Pfizer | Small molecule | 2037-01-12 | 4 patents | Method of Use Other |
| Magnesium Sulfate (Magnesium Sulfate) | Pfizer | Small molecule | 2037-08-04 | 4 patents | Formulation Method of Use |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2037-05-18 | 4 patents | Method of Use |
| Victoza (liraglutide) | Novo Nordisk | Small molecule | 2037-01-09 | 4 patents | Method of Use Other |
| Xerava (ERAVACYCLINE DIHYDROCHLORIDE) | Tetraphase Pharms | Small molecule | 2037-10-19 | 4 patents | Composition of Matter |
| pilocarpine-hydrochloride (PILOCARPINE HYDROCHLORIDE) | — | Small molecule | 2037-08-18 | 4 patents | Method of Use |
| pimavanserin-tartrate (PIMAVANSERIN TARTRATE) | — | Small molecule | 2037-03-23 | 4 patents | Method of Use Other |
| chembl-chembl2106195 (DEXMEDETOMIDINE HYDROCHLORIDE) | — | Small molecule | 2037-12-29 | 4 patents | Method of Use |
| Aqneursa (LEVACETYLLEUCINE) | Intrabio | Small molecule | 2037-04-19 | 3 patents | Method of Use |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2037-11-16 | 3 patents | Formulation Method of Use |
| Komzifti (ZIFTOMENIB) | Kura | Small molecule | 2037-01-26 | 3 patents | Composition of Matter Method of Use |
| Palbociclib (palbociclib) | Pfizer Inc. | Small molecule | 2037-02-19 | 3 patents | Other |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2037-02-28 | 3 patents | Formulation Method of Use |
| Xtandi (enzalutamide) | Astellas Pharma | Small molecule | 2037-02-23 | 3 patents | Method of Use |
| benoxinate-hydrochloride (BENOXINATE HYDROCHLORIDE) | — | Small molecule | 2037-11-15 | 3 patents | Method of Use |
| Ekterly (SEBETRALSTAT) | Kalvista | Small molecule | 2037-06-23 | 2 patents | Composition of Matter Method of Use |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2037-09-29 | 2 patents | Method of Use |
| Lioresal (BACLOFEN) | — | Small molecule | 2037-09-08 | 2 patents | Formulation Method of Use |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2037-10-12 | 2 patents | Formulation |
| Ztalmy (GANAXOLONE) | Marinus | Small molecule | 2037-08-10 | 2 patents | Method of Use |
| thiotepa (THIOTEPA) | — | Small molecule | 2037-05-31 | 2 patents | Formulation |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2037-09-08 | 2 patents | Method of Use |
| elacestrant-hydrochloride (ELACESTRANT HYDROCHLORIDE) | — | Small molecule | 2037-02-28 | 2 patents | Method of Use |
| Arnicare Leg Cramps (COPPER) | Sebela Womens Hlth | Small molecule | 2037-01-23 | 1 patents | Formulation |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2037-11-28 | 1 patents | Method of Use |
| Cipro (Ciprofloxacin) | Alk Abello | Small molecule | 2037-11-12 | 1 patents | Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2037-12-20 | 1 patents | Formulation |
| Ecclock (SOFPIRONIUM BROMIDE) | Kaken Pharmaceutical | Small molecule | 2037-07-20 | 1 patents | Method of Use |
| Krazati (ADAGRASIB) | Bristol-Myers Squibb | Small molecule | 2037-05-17 | 1 patents | Method of Use |
| Miebo (PERFLUOROHEXYLOCTANE) | Bausch Health | Small molecule | 2037-06-21 | 1 patents | Method of Use |
| Pizensy (LACTITOL) | Braintree Labs | Small molecule | 2037-05-12 | 1 patents | Method of Use |
| Tryvio (APROCITENTAN) | Idorsia | Small molecule | 2037-11-06 | 1 patents | Method of Use |
| Zavesca (MIGLUSTAT) | AstraZeneca | Small molecule | 2037-08-12 | 1 patents | Method of Use |
| Zulresso (BREXANOLONE) | Sage Therap | Small molecule | 2037-03-08 | 1 patents | Method of Use |
| Zykadia (ceritinib) | Novartis | Small molecule | 2037-12-13 | 1 patents | Method of Use |
| ANDEMBRY (GARADACIMAB-GXII) | CSL BEHRING LLC | Biologic | 2037-06-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ARMLUPEG (PEGFILGRASTIM-UNNE) | LUPIN LTD | Biologic | 2037-11-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AVTOZMA (TOCILIZUMAB-ANOH) | CELLTRION INC | Biologic | 2037-01-24 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BILPREVDA (DENOSUMAB) | Amgen | Biologic | 2037-08-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BLENREP (BELANTAMAB MAFODOTIN) | GSK | Biologic | 2037-10-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BONCRESA (DENOSUMAB-MOBZ) | AMNEAL PHARMS LLC | Biologic | 2037-12-19 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BOSAYA | BIOCON BIOLOGICS INC | Biologic | 2037-09-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| CONEXXENCE (DENOSUMAB) | Amgen | Biologic | 2037-03-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| DATROWAY (DERUXTECAN) | Daiichi Sankyo | Biologic | 2037-01-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EMRELIS (TELISOTUZUMAB) | Abbvie Inc | Biologic | 2037-05-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENFLONSIA | MERCK SHARP DOHME | Biologic | 2037-06-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENOBY | HIKMA PHARMACEUTICALS USA INC | Biologic | 2037-09-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EXDENSUR (DEPEMOKIMAB) | Glaxosmithkline Llc | Biologic | 2037-12-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| IMAAVY (NIPOCALIMAB) | Janssen Biotech | Biologic | 2037-04-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| INSULIN DILUTING MEDIUM FOR KIRSTY | BIOCON BIOLOGICS INC | Biologic | 2037-07-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| JOBEVNE (BEVACIZUMAB-NWGD) | BIOCON BIOLOGICS INC | Biologic | 2037-04-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| KEYTRUDA QLEX (BERAHYALURONIDASE ALFA-PMPH) | MERCK SHARP DOHME | Biologic | 2037-09-19 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LECANEMAB AUTOINJECTOR (LECANEMAB-IRMB) | EISAI INC | Biologic | 2037-08-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LEROCHOL (LERODALCIBEP) | Lib Therapeutics, Inc. | Biologic | 2037-12-12 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LYNOZYFIC (LINVOSELTAMAB) | Rengeneron Pharmaceuticals, Inc. | Biologic | 2037-07-02 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MERILOG | SANOFI-AVENTIS U.S. LLC | Biologic | 2037-02-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OSPOMYV (DENOSUMAB) | Amgen | Biologic | 2037-10-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OTULFI (USTEKINUMAB-AAUZ) | FRESENIUS KABI USA | Biologic | 2037-04-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OZILTUS (DENOSUMAB-MOBZ) | AMNEAL PHARMS LLC | Biologic | 2037-12-19 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PENPULIMAB KCQX (PENPULIMAB) | Akeso Biopharma | Biologic | 2037-04-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYBREVANT FASPRO | JANSSEN BIOTECH | Biologic | 2037-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| STARJEMZA | BIO-THERA SOLUTIONS LTD | Biologic | 2037-05-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| STOBOCLO | CELLTRION INC | Biologic | 2037-02-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TYENNE (TOCILIZUMAB-AAZG) | FRESENIUS KABI USA | Biologic | 2037-03-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| USTEKINUMAB-TTWE (USTEKINUMAB-TTWE) | SAMSUNG BIOEPIS CO LTD | Biologic | 2037-04-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VOYXACT | OTSUKA PHARM CO LTD | Biologic | 2037-11-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| YARTEMLEA (NARSOPLIMAB-WUUG) | OMEROS CORP | Biologic | 2037-12-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | CELLTRION INC | Biologic | 2037-03-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SHANGHAI HENLIUS BIOTECH | Biologic | 2037-11-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BEIGENE | Biologic | 2037-03-03 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | DAIICHI SANKYO INC | Biologic | 2037-06-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ACCORD BIOPHARMA INC. | Biologic | 2037-10-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | FORMYCON AG | Biologic | 2037-12-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | MERCK SHARP AND DOHME LLC | Biologic | 2037-10-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | NOVO NORDISK INC | Biologic | 2037-07-31 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | CELLTRION INC | Biologic | 2037-10-02 | 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.