Patent Cliff Calendar
Drugs losing US patent exclusivity in 2036
134 drugs face loss of exclusivity in 2036 · 92 small-molecule via Orange Book · 42 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.
2036 is long-dated (10 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2036
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2036-03-07 | 132 patents | Method of Use Other |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2036-04-11 | 74 patents | Formulation Method of Use |
| Rinvoq (upadacitinib) | AbbVie Inc. | Small molecule | 2036-10-17 | 71 patents | Composition of Matter Formulation Method of Use |
| Mounjaro (TIRZEPATIDE) | Eli Lilly | Small molecule | 2036-01-05 | 48 patents | Composition of Matter Method of Use |
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2036-03-03 | 36 patents | Formulation Other |
| sodium-phenylbutyrate (SODIUM PHENYLBUTYRATE) | — | Small molecule | 2036-10-17 | 24 patents | Formulation Method of Use |
| OxyContin (oxycodone) | Purdue Pharma | Small molecule | 2036-09-02 | 20 patents | Method of Use |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2036-12-01 | 16 patents | Method of Use |
| cysteamine-bitartrate (CYSTEAMINE BITARTRATE) | — | Small molecule | 2036-08-16 | 16 patents | Method of Use |
| vosoritide (VOSORITIDE) | — | Small molecule | 2036-08-01 | 15 patents | Formulation Method of Use |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2036-04-27 | 12 patents | Composition of Matter Method of Use |
| Glucagen (GLUCAGON) | Xeris | Small molecule | 2036-02-16 | 11 patents | Method of Use |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2036-07-20 | 10 patents | Formulation |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2036-04-29 | 10 patents | Method of Use Other |
| Balversa (ERDAFITINIB) | Johnson & Johnson | Small molecule | 2036-02-09 | 9 patents | Method of Use |
| Vasotec (ENALAPRIL MALEATE) | Azurity | Small molecule | 2036-03-25 | 9 patents | Formulation Method of Use |
| Aldactone (spironolactone) | Generic (originally Searle/Pfizer) | Small molecule | 2036-10-28 | 8 patents | Formulation Method of Use |
| Augtyro (REPOTRECTINIB) | Bristol | Small molecule | 2036-07-05 | 8 patents | Composition of Matter Formulation Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2036-02-23 | 8 patents | Method of Use Other |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2036-04-20 | 7 patents | Method of Use |
| Velsipity (Etrasimod Arginine) | Pfizer Inc. | Small molecule | 2036-01-06 | 7 patents | Composition of Matter Method of Use |
| Celebrex (celecoxib) | Pfizer Inc. (originally Searle/Pharmacia) | Small molecule | 2036-05-27 | 6 patents | Method of Use |
| Cytoxan (Lyophilized) (cyclophosphamide) | Baxter | Small molecule | 2036-02-15 | 6 patents | Formulation |
| Daurismo (Glasdegib Maleate) | Pfizer | Small molecule | 2036-04-13 | 6 patents | Composition of Matter Method of Use |
| Itovebi (INAVOLISIB) | Genentech Inc | Small molecule | 2036-07-01 | 6 patents | Composition of Matter Method of Use |
| Mayzent (SIPONIMOD) | Novartis | Small molecule | 2036-04-23 | 6 patents | Method of Use |
| Ocaliva (OBETICHOLIC ACID) | Intercept Pharms Inc | Small molecule | 2036-04-26 | 6 patents | Formulation Method of Use |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2036-12-02 | 6 patents | Method of Use |
| Taxotere (Docetaxel) | Sanofi | Small molecule | 2036-03-14 | 6 patents | Formulation Method of Use |
| pexidartinib-hydrochloride (PEXIDARTINIB HYDROCHLORIDE) | — | Small molecule | 2036-05-05 | 6 patents | Composition of Matter Method of Use |
| tapinarof (TAPINAROF) | — | Small molecule | 2036-05-19 | 6 patents | Formulation Method of Use |
| vadadustat (VADADUSTAT) | — | Small molecule | 2036-03-31 | 6 patents | Formulation Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2036-11-22 | 5 patents | Formulation Method of Use |
| Brilinta (ticagrelor) | AstraZeneca | Small molecule | 2036-01-27 | 4 patents | Method of Use Other |
| Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) | Innocoll | Small molecule | 2036-04-21 | 4 patents | Method of Use |
| Camptosar (Irinotecan Hydrochloride) | Pfizer | Small molecule | 2036-08-19 | 4 patents | Formulation Method of Use |
| Camzyos (MAVACAMTEN) | Bristol-Myers Squibb | Small molecule | 2036-04-28 | 4 patents | Composition of Matter |
| Invega Sustenna (PALIPERIDONE PALMITATE) | Johnson & Johnson | Small molecule | 2036-04-05 | 4 patents | Method of Use |
| Lorbrena (lorlatinib) | Pfizer | Small molecule | 2036-07-27 | 4 patents | Formulation Method of Use |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2036-09-09 | 4 patents | Method of Use |
| Rapamune (sirolimus) | Pfizer | Small molecule | 2036-03-05 | 4 patents | Formulation Method of Use |
| Slynd (DROSPIRENONE) | Exeltis Usa Inc | Small molecule | 2036-06-17 | 4 patents | Formulation Method of Use |
| donepezil-hydrochloride (DONEPEZIL HYDROCHLORIDE) | — | Small molecule | 2036-12-30 | 4 patents | Method of Use |
| chembl-chembl2106195 (DEXMEDETOMIDINE HYDROCHLORIDE) | — | Small molecule | 2036-04-20 | 4 patents | Formulation |
| Evrysdi (RISDIPLAM) | Roche | Small molecule | 2036-01-25 | 3 patents | Formulation Method of Use |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2036-02-12 | 3 patents | Formulation Method of Use Other |
| Monoferric (FERRIC DERISOMALTOSE) | Pharmacosmos | Small molecule | 2036-06-22 | 3 patents | Method of Use |
| Nexletol (BEMPEDOIC ACID) | Esperion Theraps Inc | Small molecule | 2036-03-14 | 3 patents | Method of Use |
| Nubeqa (darolutamide) | Bayer | Small molecule | 2036-01-28 | 3 patents | Composition of Matter Method of Use |
| Palbociclib (palbociclib) | Pfizer Inc. | Small molecule | 2036-08-19 | 3 patents | Formulation |
| Xolremdi (MAVORIXAFOR) | X4 Pharms | Small molecule | 2036-12-14 | 3 patents | Formulation Method of Use |
| dextromethorphan-hydrobromide (DEXTROMETHORPHAN HYDROBROMIDE) | — | Small molecule | 2036-10-11 | 3 patents | Formulation |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2036-04-14 | 3 patents | Formulation |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2036-09-04 | 3 patents | Method of Use |
| chembl-chembl3655081 (ABROCITINIB) | — | Small molecule | 2036-01-14 | 3 patents | Composition of Matter |
| Calquence (ACALABRUTINIB) | AstraZeneca | Small molecule | 2036-07-01 | 2 patents | Method of Use |
| Cleocin T (CLINDAMYCIN PHOSPHATE) | Pfizer | Small molecule | 2036-09-22 | 2 patents | Formulation Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2036-10-20 | 2 patents | Method of Use |
| Komzifti (ZIFTOMENIB) | Kura | Small molecule | 2036-03-16 | 2 patents | Composition of Matter Method of Use |
| Lotemax (LOTEPREDNOL ETABONATE) | Bausch Health | Small molecule | 2036-01-26 | 2 patents | Method of Use |
| Lytgobi (futibatinib) | Taiho Oncology | Small molecule | 2036-03-31 | 2 patents | Composition of Matter |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2036-06-24 | 2 patents | Formulation Other |
| Myrbetriq (MIRABEGRON) | Apgdi | Small molecule | 2036-03-31 | 2 patents | Method of Use Other |
| Pifeltro (DORAVIRINE) | Merck & Co. | Small molecule | 2036-11-29 | 2 patents | Formulation |
| Prevacid (lansoprazole) | Generic (originally Takeda) | Small molecule | 2036-04-21 | 2 patents | Formulation |
| Prilosec (omeprazole) | AstraZeneca (originally Astra AB) | Small molecule | 2036-12-08 | 2 patents | Formulation |
| Temovate (CLOBETASOL PROPIONATE) | Fougera Pharms | Small molecule | 2036-05-09 | 2 patents | Formulation Method of Use |
| Vivjoa (OTESECONAZOLE) | Mycovia Pharms | Small molecule | 2036-03-17 | 2 patents | Composition of Matter |
| Zavesca (MIGLUSTAT) | AstraZeneca | Small molecule | 2036-12-29 | 2 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2036-11-12 | 2 patents | Formulation Method of Use |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2036-04-07 | 2 patents | Formulation |
| esomeprazole-magnesium (ESOMEPRAZOLE MAGNESIUM) | — | Small molecule | 2036-12-08 | 2 patents | Formulation |
| bictegravir-sodium (BICTEGRAVIR SODIUM) | — | Small molecule | 2036-11-08 | 2 patents | Formulation |
| chembl-chembl225072 (PEMETREXED) | — | Small molecule | 2036-02-19 | 2 patents | Formulation Method of Use |
| elacestrant-hydrochloride (ELACESTRANT HYDROCHLORIDE) | — | Small molecule | 2036-10-03 | 2 patents | Method of Use |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2036-10-07 | 1 patents | Method of Use |
| Exem Foam Kit (AIR POLYMER-TYPE A) | Giskit | Small molecule | 2036-02-11 | 1 patents | Formulation |
| Gavreto (PRALSETINIB) | Rigel Pharms | Small molecule | 2036-11-01 | 1 patents | Method of Use |
| Kygevvi (DOXECITINE) | Ucb Inc | Small molecule | 2036-08-07 | 1 patents | Method of Use |
| Lumigan (BIMATOPROST) | — | Small molecule | 2036-06-08 | 1 patents | Method of Use |
| Miebo (PERFLUOROHEXYLOCTANE) | Bausch Health | Small molecule | 2036-09-29 | 1 patents | Formulation |
| Moizerto (DIFAMILAST) | OTSUKA PHARMACEUTICAL Co., Ltd | Small molecule | 2036-12-31 | 1 patents | Composition of Matter |
| Orgovyx (relugolix) | MYOVANT SCIENCES | Small molecule | 2036-02-25 | 1 patents | Formulation |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2036-09-29 | 1 patents | Method of Use |
| Tibsovo (IVOSIDENIB) | Servier | Small molecule | 2036-10-18 | 1 patents | Method of Use |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2036-01-14 | 1 patents | Formulation |
| eflornithine-hydrochloride (EFLORNITHINE HYDROCHLORIDE) | — | Small molecule | 2036-02-12 | 1 patents | Method of Use |
| isopropyl-alcohol (ISOPROPYL ALCOHOL) | — | Small molecule | 2036-04-24 | 1 patents | Method of Use |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2036-06-29 | 1 patents | Formulation |
| elinzanetant (ELINZANETANT) | — | Small molecule | 2036-05-18 | 1 patents | Method of Use |
| nusinersen-sodium (NUSINERSEN SODIUM) | — | Small molecule | 2036-03-04 | 1 patents | Method of Use |
| givinostat-hydrochloride (GIVINOSTAT HYDROCHLORIDE) | — | Small molecule | 2036-10-28 | 1 patents | Method of Use |
| ADALIMUMAB-RYVK (ADALIMUMAB-RYVK) | ALVOTECH USA INC | Biologic | 2036-02-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AHZANTIVE (AFLIBERCEPT-MRBB) | FORMYCON AG | Biologic | 2036-06-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ALHEMO (CONCIZUMAB-MTCI) | NOVO NORDISK INC | Biologic | 2036-12-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ANKTIVA (nogapendekin alfa inbakicept-pmln) | ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU | Biologic | 2036-04-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BIZENGRI (ZENOCUTUZUMAB-ZBCO) | MERUS N.V. | Biologic | 2036-12-04 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BKEMV (ECULIZUMAB-AEEB) | AMGEN INC | Biologic | 2036-05-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EBGLYSS (LEBRIKIZUMAB-LBKZ) | ELI LILLY AND CO | Biologic | 2036-09-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EPYSQLI (ECULIZUMAB-AAGH) | SAMSUNG BIOEPIS CO LTD | Biologic | 2036-07-19 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| HYMPAVZI (Marstacimab-Hncq) | Pfizer Inc. | Biologic | 2036-10-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| IDACIO (ADALIMUMAB-AACF) | FRESENIUS KABI USA | Biologic | 2036-01-05 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| IMDELLTRA (AMG757) (TARLATAMAB) | Amgen Inc | Biologic | 2036-05-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| IMULDOSA (USTEKINUMAB-SRLF) | ACCORD BIOPHARMA INC. | Biologic | 2036-10-10 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| KISUNLA (DONANEMAB-AZBT) | ELI LILLY CO | Biologic | 2036-07-02 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LETYBO (LETIBOTULINUMTOXINA-WLBG) | HUGEL INC | Biologic | 2036-02-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LYMPHIR (DENILEUKIN DIFTITOX-CXDL) | CITIUS PHARMS | Biologic | 2036-08-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NEMLUVIO | GALDERMA LABS LP | Biologic | 2036-08-12 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NIKTIMVO (AXATILIMAB) | Incyte Corp | Biologic | 2036-08-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NYPOZI TXID (FILGRASTIM-TXID) | TANVEX BIOPHARMA USA INC | Biologic | 2036-06-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OCREVUS ZUNOVO | GENENTECH INC | Biologic | 2036-09-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OPDIVO QVANTIG (HYALURONIDASE-NVHY) | BRISTOL-MYERS SQUIBB | Biologic | 2036-12-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PAVBLU (AFLIBERCEPT-AYYH) | AMGEN INC | Biologic | 2036-08-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PIASKY (CROVALIMAB-AKKZ) | GENENTECH INC | Biologic | 2036-06-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SELARSDI (USTEKINUMAB-AEKN) | ALVOTECH USA INC | Biologic | 2036-04-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| STEQEYMA (USTEKINUMAB-STBA) | CELLTRION, INC. | Biologic | 2036-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TECENTRIQ HYBREZA | GENENTECH INC | Biologic | 2036-09-12 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TEVIMBRA (islelizumab-jsgr) | BEIGENE | Biologic | 2036-03-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TYENNE (TOCILIZUMAB-AAZG) | FRESENIUS KABI USA | Biologic | 2036-03-05 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| UNLOXCYT (COSIBELIMAB) | Checkpoint Therapeutics Inc | Biologic | 2036-12-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| USTEKINUMAB-TTWE (USTEKINUMAB-TTWE) | SAMSUNG BIOEPIS CO LTD | Biologic | 2036-06-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VYLOY (ZOLBETUXIMAB) | Astellas | Biologic | 2036-10-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| WINREVAIR (SOTATERCEPT-CSRK) | MERCK SHARP DOHME | Biologic | 2036-03-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| WYOST (DENOSUMAB) | Amgen | Biologic | 2036-03-05 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| YESINTEK (ustekinumab) | Johnson & Johnson | Biologic | 2036-11-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZIIHERA (ZANIDATAMAB) | Jazz Pharms | Biologic | 2036-11-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BRISTOL-MYERS SQUIBB | Biologic | 2036-12-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SAMSUNG BIOEPIS CO LTD | Biologic | 2036-05-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SANDOZ INC | Biologic | 2036-08-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | TAKEDA PHARMS USA | Biologic | 2036-04-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ACCORD BIOPHARMA INC. | Biologic | 2036-04-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | GALDERMA LABS LP | Biologic | 2036-12-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BIOCON BIOLOGICS INC | Biologic | 2036-05-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BEIGENE | Biologic | 2036-12-26 | 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 2026-05-18. Patent term extensions, supplementary protection certificates, pediatric exclusivity, and pending IPR challenges may shift the effective expiry date. Not legal advice.