Patent Cliff Calendar
Drugs losing US patent exclusivity in 2031
151 drugs face loss of exclusivity in 2031 · 128 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.
2031 is a mid-term cliff (5 years away). Lifecycle moves — subcutaneous formulations, label extensions, combination filings — typically execute 18-36 months ahead of expiry.
Drugs losing exclusivity in 2031
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2031-06-03 | 117 patents | Method of Use Other |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2031-12-05 | 42 patents | Composition of Matter Formulation Method of Use |
| Zyprexa (olanzapine) | Eli Lilly | Small molecule | 2031-08-23 | 36 patents | Composition of Matter Method of Use |
| Bylvay (ODEVIXIBAT) | Ipsen | Small molecule | 2031-11-08 | 32 patents | Method of Use |
| Slynd (DROSPIRENONE) | Exeltis Usa Inc | Small molecule | 2031-06-28 | 31 patents | Formulation Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2031-02-14 | 29 patents | Formulation Method of Use Other |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2031-05-31 | 28 patents | Formulation Method of Use |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2031-01-06 | 26 patents | Formulation Method of Use Other |
| Talzenna (Talazoparib Tosylate) | Pfizer Inc. | Small molecule | 2031-10-20 | 24 patents | Composition of Matter |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2031-05-18 | 24 patents | Formulation |
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2031-04-03 | 22 patents | Composition of Matter Other |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2031-01-28 | 22 patents | Formulation Method of Use Other |
| Fanapt (ILOPERIDONE) | Vanda Pharms Inc | Small molecule | 2031-01-16 | 21 patents | Method of Use |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2031-03-20 | 21 patents | Composition of Matter Method of Use Other |
| milsaperidone (Milsaperidone) | Vanda Pharmaceuticals | Small molecule | 2031-01-16 | 21 patents | Method of Use |
| Sohonos (PALOVAROTENE) | Ipsen | Small molecule | 2031-08-31 | 20 patents | Method of Use |
| Subutex (BUPRENORPHINE) | Purdue Pharma Lp | Small molecule | 2031-06-06 | 16 patents | Formulation Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2031-02-28 | 16 patents | Formulation Method of Use |
| Verquvo (VERICIGUAT) | Merck & Co. | Small molecule | 2031-05-19 | 15 patents | Composition of Matter Method of Use |
| lurasidone-hydrochloride (LURASIDONE HYDROCHLORIDE) | — | Small molecule | 2031-05-23 | 15 patents | Method of Use Other |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2031-07-11 | 12 patents | Formulation |
| Linzess (LINACLOTIDE) | AbbVie | Small molecule | 2031-02-17 | 12 patents | Formulation Method of Use Other |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2031-07-31 | 12 patents | Formulation |
| Vocabria (CABOTEGRAVIR) | GSK | Small molecule | 2031-02-04 | 11 patents | Composition of Matter Formulation Method of Use |
| Diprolene (BETAMETHASONE DIPROPIONATE) | Merck & Co. | Small molecule | 2031-06-10 | 10 patents | Formulation Method of Use Other |
| Cleviprex (CLEVIDIPINE) | Chiesi | Small molecule | 2031-10-10 | 9 patents | Formulation |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2031-05-12 | 9 patents | Other |
| Uptravi (SELEXIPAG) | AstraZeneca | Small molecule | 2031-02-01 | 9 patents | Other |
| Barhemsys (AMISULPRIDE) | Acacia | Small molecule | 2031-03-10 | 8 patents | Formulation Method of Use |
| Keppra (levetiracetam) | Generic (originally UCB Pharma) | Small molecule | 2031-06-07 | 8 patents | Formulation Other |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2031-05-27 | 8 patents | Formulation |
| chembl-chembl43452 (POMALIDOMIDE) | — | Small molecule | 2031-06-21 | 8 patents | Composition of Matter Other |
| Alphagan (BRIMONIDINE TARTRATE) | Senju Pharmaceutical Co., Ltd | Small molecule | 2031-03-25 | 7 patents | Formulation Method of Use |
| Merrem (Meropenem) | Pfizer | Small molecule | 2031-08-08 | 7 patents | Composition of Matter Formulation Method of Use |
| Mitozytrex (MITOMYCIN) | Kyowa Kirin Co., Ltd. | Small molecule | 2031-01-20 | 7 patents | Formulation Method of Use |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2031-02-22 | 7 patents | Composition of Matter Method of Use |
| Eliquis (apixaban) | Bristol-Myers Squibb | Small molecule | 2031-02-24 | 6 patents | Formulation Other |
| Olumiant (baricitinib) | Eli Lilly | Small molecule | 2031-11-02 | 6 patents | Method of Use |
| Pulmicort Respules (BUDESONIDE) | AstraZeneca K.K. | Small molecule | 2031-03-17 | 6 patents | Formulation Method of Use |
| Venclexta (venetoclax) | AbbVie | Small molecule | 2031-06-27 | 6 patents | Composition of Matter |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2031-05-05 | 6 patents | Formulation |
| cabozantinib-s-malate (CABOZANTINIB S-MALATE) | — | Small molecule | 2031-07-18 | 6 patents | Method of Use |
| Arnuity Ellipta (FLUTICASONE FUROATE) | Haleon Us Holdings | Small molecule | 2031-04-11 | 5 patents | Other |
| Invega Sustenna (PALIPERIDONE PALMITATE) | Johnson & Johnson | Small molecule | 2031-01-26 | 5 patents | Method of Use |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2031-05-12 | 5 patents | Formulation Method of Use |
| Aloprim (ALLOPURINOL) | Casper Pharma Llc | Small molecule | 2031-08-01 | 4 patents | Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2031-03-30 | 4 patents | Other |
| Jevtana Kit (cabazitaxel) | Accord Hlthcare | Small molecule | 2031-04-27 | 4 patents | Other |
| Rinvoq (upadacitinib) | AbbVie Inc. | Small molecule | 2031-01-15 | 4 patents | Method of Use |
| Ubrelvy (UBROGEPANT) | AbbVie | Small molecule | 2031-11-10 | 4 patents | Method of Use |
| Uloric (FEBUXOSTAT) | Takeda | Small molecule | 2031-09-08 | 4 patents | Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2031-09-16 | 4 patents | Composition of Matter |
| Verzenio (abemaciclib) | Eli Lilly | Small molecule | 2031-09-28 | 4 patents | Method of Use |
| Alunbrig (brigatinib) | Takeda | Small molecule | 2031-04-28 | 3 patents | Composition of Matter |
| Balversa (ERDAFITINIB) | Johnson & Johnson | Small molecule | 2031-04-28 | 3 patents | Method of Use |
| Lynparza (olaparib) | AstraZeneca | Small molecule | 2031-08-04 | 3 patents | Method of Use |
| Parsabiv (ETELCALCETIDE) | Kai Pharms Inc | Small molecule | 2031-02-07 | 3 patents | Method of Use |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2031-11-10 | 3 patents | Method of Use |
| Sodium Nitrite (SODIUM NITRITE) | Hope Pharms | Small molecule | 2031-03-29 | 3 patents | Composition of Matter Method of Use |
| Taxotere (Docetaxel) | Sanofi | Small molecule | 2031-08-07 | 3 patents | Method of Use |
| Trulance (PLECANATIDE) | Salix | Small molecule | 2031-09-15 | 3 patents | Formulation Method of Use |
| Tryptyr (ACOLTREMON) | Alcon Labs Inc | Small molecule | 2031-09-08 | 3 patents | Method of Use |
| Yorvipath (PALOPEGTERIPARATIDE) | Ascendis Pharma Bone | Small molecule | 2031-04-30 | 3 patents | Method of Use |
| afatinib-dimaleate (AFATINIB DIMALEATE) | — | Small molecule | 2031-01-05 | 3 patents | Other |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2031-03-13 | 3 patents | Composition of Matter Method of Use |
| pitavastatin-magnesium (PITAVASTATIN MAGNESIUM) | — | Small molecule | 2031-01-19 | 3 patents | Composition of Matter |
| Aubagio (TERIFLUNOMIDE) | Sanofi | Small molecule | 2031-03-14 | 2 patents | Other |
| Bevyxxa (BETRIXABAN) | Portola Pharms Inc | Small molecule | 2031-03-29 | 2 patents | Method of Use |
| Braftovi (encorafenib) | Pfizer | Small molecule | 2031-07-04 | 2 patents | Method of Use |
| Brenzavvy (BEXAGLIFLOZIN) | Theracosbio | Small molecule | 2031-06-13 | 2 patents | Composition of Matter Method of Use |
| Catapres-Tts-1 (CLONIDINE) | Lavipharm | Small molecule | 2031-09-08 | 2 patents | Formulation |
| Dayvigo (LEMBOREXANT) | Eisai | Small molecule | 2031-09-20 | 2 patents | Method of Use |
| Inlyta (Axitinib) | Pfizer | Small molecule | 2031-06-14 | 2 patents | Other |
| Letairis (AMBRISENTAN) | Gilead Sciences | Small molecule | 2031-10-14 | 2 patents | Method of Use |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2031-05-06 | 2 patents | Other |
| Mytesi (CROFELEMER) | Napo Pharms Inc | Small molecule | 2031-10-31 | 2 patents | Method of Use |
| Ojemda (TOVORAFENIB) | Day One Biopharms | Small molecule | 2031-08-04 | 2 patents | Composition of Matter |
| Teflaro (CEFTAROLINE FOSAMIL) | AbbVie | Small molecule | 2031-02-10 | 2 patents | Method of Use |
| Tembexa (BRINCIDOFOVIR) | Emergent Biodefense | Small molecule | 2031-08-31 | 2 patents | Method of Use |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2031-03-05 | 2 patents | Method of Use Other |
| Tukysa (tucatinib) | Seagen | Small molecule | 2031-01-14 | 2 patents | Composition of Matter |
| Tymlos (ABALOPARATIDE) | Radius | Small molecule | 2031-04-28 | 2 patents | Method of Use |
| Vivjoa (OTESECONAZOLE) | Mycovia Pharms | Small molecule | 2031-04-22 | 2 patents | Composition of Matter Method of Use |
| Zurampic (LESINURAD) | Ironwood Pharms Inc | Small molecule | 2031-08-01 | 2 patents | Method of Use |
| chembl-chembl1200775 (LEUPROLIDE ACETATE) | — | Small molecule | 2031-02-05 | 2 patents | Formulation Method of Use |
| fostamatinib-disodium (FOSTAMATINIB DISODIUM) | — | Small molecule | 2031-09-04 | 2 patents | Composition of Matter |
| telotristat-etiprate (TELOTRISTAT ETIPRATE) | — | Small molecule | 2031-02-27 | 2 patents | Composition of Matter Method of Use |
| capmatinib-hydrochloride (CAPMATINIB HYDROCHLORIDE) | — | Small molecule | 2031-06-05 | 2 patents | Composition of Matter |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2031-06-11 | 2 patents | Method of Use |
| posaconazole (POSACONAZOLE) | — | Small molecule | 2031-06-24 | 2 patents | Method of Use |
| chembl-chembl1946170 (REGORAFENIB) | — | Small molecule | 2031-02-16 | 2 patents | Composition of Matter Formulation |
| Accrufer (FERRIC MALTOL) | Shield Tx | Small molecule | 2031-03-29 | 1 patents | Method of Use |
| Acetadote (Acetylcysteine) | Bristol-Myers Squibb | Small molecule | 2031-07-21 | 1 patents | Method of Use |
| Akynzeo (NETUPITANT) | Helsinn Hlthcare | Small molecule | 2031-09-09 | 1 patents | Method of Use |
| Celebrex (celecoxib) | Pfizer Inc. (originally Searle/Pharmacia) | Small molecule | 2031-06-03 | 1 patents | Formulation |
| Corectim (DELGOCITINIB) | Japan Tobacco | Small molecule | 2031-09-19 | 1 patents | Method of Use |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2031-10-03 | 1 patents | Method of Use |
| Imitrex (SUMATRIPTAN) | GSK | Small molecule | 2031-07-19 | 1 patents | Method of Use |
| Inrebic (FEDRATINIB HYDROCHLORIDE) | Bristol-Myers Squibb | Small molecule | 2031-11-16 | 1 patents | Composition of Matter |
| Intrarosa (PRASTERONE) | — | Small molecule | 2031-03-19 | 1 patents | Formulation |
| Livtencity (MARIBAVIR) | Takeda | Small molecule | 2031-10-27 | 1 patents | Method of Use |
| Lumigan (BIMATOPROST) | — | Small molecule | 2031-07-15 | 1 patents | Composition of Matter |
| Mektovi (binimetinib) | Pfizer | Small molecule | 2031-07-04 | 1 patents | Method of Use |
| Mulpleta (LUSUTROMBOPAG) | Vancocin Italia | Small molecule | 2031-09-29 | 1 patents | Formulation |
| Nuzyra (OMADACYCLINE TOSYLATE) | Paratek Pharms | Small molecule | 2031-03-18 | 1 patents | Formulation |
| Ohtuvayre (ENSIFENTRINE) | Verona Pharma | Small molecule | 2031-08-21 | 1 patents | Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2031-02-25 | 1 patents | Formulation |
| Sodium Thiosulfate (SODIUM THIOSULFATE) | Us Army | Small molecule | 2031-03-29 | 1 patents | Method of Use |
| Spiriva (TIOTROPIUM BROMIDE) | Boehringer Ingelheim | Small molecule | 2031-04-16 | 1 patents | Other |
| Tavneos (AVACOPAN) | Chemocentryx | Small molecule | 2031-02-03 | 1 patents | Composition of Matter |
| Travatan (TRAVOPROST) | — | Small molecule | 2031-02-14 | 1 patents | Composition of Matter |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2031-08-06 | 1 patents | Formulation |
| Veozah (FEZOLINETANT) | Astellas Pharma | Small molecule | 2031-04-04 | 1 patents | Composition of Matter |
| Viltepso (VILTOLARSEN) | Nippon Shinyaku | Small molecule | 2031-08-31 | 1 patents | Method of Use |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2031-07-08 | 1 patents | Method of Use |
| Xtoro (FINAFLOXACIN) | Fonseca Biosciences | Small molecule | 2031-08-08 | 1 patents | Method of Use |
| Yupelri (REVEFENACIN) | Mylan Ireland Ltd | Small molecule | 2031-08-25 | 1 patents | Composition of Matter |
| Zavzpret (Zavegepant Hydrochloride) | Pfizer | Small molecule | 2031-10-07 | 1 patents | Method of Use |
| Zepatier (ELBASVIR) | Merck & Co. | Small molecule | 2031-05-04 | 1 patents | Method of Use |
| Ztalmy (GANAXOLONE) | Marinus | Small molecule | 2031-11-28 | 1 patents | Formulation |
| trifarotene (TRIFAROTENE) | — | Small molecule | 2031-07-19 | 1 patents | Composition of Matter |
| oxybutynin-chloride (OXYBUTYNIN CHLORIDE) | — | Small molecule | 2031-03-26 | 1 patents | Method of Use |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2031-09-03 | 1 patents | Formulation |
| sufentanil-citrate (SUFENTANIL CITRATE) | — | Small molecule | 2031-07-29 | 1 patents | Formulation |
| alectinib-hydrochloride (ALECTINIB HYDROCHLORIDE) | — | Small molecule | 2031-05-29 | 1 patents | Composition of Matter |
| solifenacin-succinate (SOLIFENACIN SUCCINATE) | — | Small molecule | 2031-05-18 | 1 patents | Formulation |
| econazole-nitrate (ECONAZOLE NITRATE) | — | Small molecule | 2031-08-08 | 1 patents | Formulation |
| neratinib-maleate (NERATINIB MALEATE) | — | Small molecule | 2031-07-18 | 1 patents | Method of Use |
| ABRILADA (Adalimumab-Afzb) | AbbVie | Biologic | 2031-11-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ADAKVEO (CRIZANLIZUMAB) | Novartis | Biologic | 2031-11-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ADALIMUMAB-BWWD (ADALIMUMAB-BWWD) | SAMSUNG BIOEPIS CO LTD | Biologic | 2031-07-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AVSOLA (INFLIXIMAB-AXXQ) | AMGEN INC | Biologic | 2031-12-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BEOVU (BROLUCIZUMAB) | Novartis | Biologic | 2031-10-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| CABLIVI (CAPLACIZUMAB-YHDP) | ABLYNX NV | Biologic | 2031-02-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENHERTU (trastuzumab-deruxtecan) | Daiichi Sankyo | Biologic | 2031-12-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EVENITY (ROMOSOZUMAB-AQQG) | AMGEN INC | Biologic | 2031-04-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| HERCEPTIN HYLECTA (Trastuzumab and Hyaluronidase-oysk) | Adrienne G. Waks | Biologic | 2031-02-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Ilumya (TILDRAKIZUMAB) | Sun Pharma Global | Biologic | 2031-06-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| JEUVEAU | EVOLUS INC | Biologic | 2031-02-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MYXREDLIN (INSULIN HUMAN) | BAXTER HLTHCARE CORP | Biologic | 2031-06-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NUCALA (MEPOLIZUMAB) | GSK | Biologic | 2031-06-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ONTRUZANT (TRASTUZUMAB-DTTB) | SAMSUNG BIOEPIS CO LTD | Biologic | 2031-01-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PADCEV EJFV (ENFORTUMAB VEDOTIN) | ASTELLAS | Biologic | 2031-12-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| POLIVY (POLATUZUMAB VEDOTIN) | Roche | Biologic | 2031-06-10 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| REBLOZYL (LUSPATERCEPT-AAMT) | CELGENE CORP | Biologic | 2031-11-08 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RUXIENCE (Rituximab-Pvvr) | Roche | Biologic | 2031-07-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SKYRIZI (RISANKIZUMAB) | AbbVie | Biologic | 2031-04-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TRAZIMERA (Trastuzumab-Qyyp) | Roche | Biologic | 2031-03-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZIEXTENZO (PEGFILGRASTIM-BMEZ) | SANDOZ INC | Biologic | 2031-11-04 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZIRABEV (Bevacizumab-Bvzr) | Roche | Biologic | 2031-06-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | SAMSUNG BIOEPIS CO LTD | Biologic | 2031-04-25 | 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.