Patent Cliff Calendar
Drugs losing US patent exclusivity in 2032
122 drugs face loss of exclusivity in 2032 · 101 small-molecule via Orange Book · 21 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.
2032 is a mid-term cliff (6 years away). Lifecycle moves — subcutaneous formulations, label extensions, combination filings — typically execute 18-36 months ahead of expiry.
Drugs losing exclusivity in 2032
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2032-11-21 | 76 patents | Composition of Matter Formulation Method of Use |
| Subutex (Buprenorphine Hydrochloride) | Indivior | Small molecule | 2032-08-20 | 49 patents | Formulation Method of Use |
| Subutex (BUPRENORPHINE) | Purdue Pharma Lp | Small molecule | 2032-01-06 | 44 patents | Formulation Method of Use |
| chembl-chembl2106195 (DEXMEDETOMIDINE HYDROCHLORIDE) | — | Small molecule | 2032-01-04 | 38 patents | Formulation Method of Use Other |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2032-04-10 | 20 patents | Formulation Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2032-03-07 | 15 patents | Method of Use Other |
| Olinvyk (OLICERIDINE) | Trevena | Small molecule | 2032-03-23 | 15 patents | Method of Use |
| fosnetupitant-chloride-hydrochloride (FOSNETUPITANT CHLORIDE HYDROCHLORIDE) | — | Small molecule | 2032-05-23 | 14 patents | Composition of Matter Method of Use |
| cabozantinib-s-malate (CABOZANTINIB S-MALATE) | — | Small molecule | 2032-02-10 | 12 patents | Formulation Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2032-08-15 | 11 patents | Formulation Method of Use |
| Olumiant (baricitinib) | Eli Lilly | Small molecule | 2032-05-31 | 9 patents | Composition of Matter Method of Use |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2032-12-28 | 9 patents | Composition of Matter Formulation |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2032-08-29 | 9 patents | Formulation |
| bromocriptine-mesylate (BROMOCRIPTINE MESYLATE) | — | Small molecule | 2032-04-30 | 9 patents | Method of Use |
| Aristada (ARIPIPRAZOLE LAUROXIL) | Alkermes Inc | Small molecule | 2032-03-19 | 8 patents | Method of Use |
| Copiktra (DUVELISIB) | Secura | Small molecule | 2032-01-10 | 8 patents | Composition of Matter Formulation Method of Use |
| Daybue (TROFINETIDE) | Acadia Pharms Inc | Small molecule | 2032-01-27 | 8 patents | Method of Use Other |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2032-01-19 | 8 patents | Composition of Matter Method of Use Other |
| Acetadote (Acetylcysteine) | Bristol-Myers Squibb | Small molecule | 2032-04-06 | 7 patents | Formulation Method of Use |
| Dilaudid-Hp (Hydromorphone Hydrochloride) | Fresenius Kabi | Small molecule | 2032-04-23 | 7 patents | Formulation |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2032-11-07 | 7 patents | Formulation Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2032-06-13 | 6 patents | Formulation |
| Emtriva (EMTRICITABINE) | Gilead Sciences | Small molecule | 2032-08-15 | 6 patents | Method of Use |
| Linzess (LINACLOTIDE) | AbbVie | Small molecule | 2032-02-11 | 6 patents | Other |
| Neupro (ROTIGOTINE) | UCB | Small molecule | 2032-03-01 | 6 patents | Formulation |
| Ritalin (methylphenidate) | Novartis | Small molecule | 2032-06-28 | 6 patents | Formulation |
| Valium (diazepam) | Generic (originally Roche) | Small molecule | 2032-06-13 | 6 patents | Method of Use |
| Venclexta (venetoclax) | AbbVie | Small molecule | 2032-01-29 | 6 patents | Composition of Matter Formulation |
| Xcopri (CENOBAMATE) | Sk Life | Small molecule | 2032-10-30 | 6 patents | Composition of Matter |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2032-10-24 | 6 patents | Composition of Matter |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2032-03-11 | 6 patents | Formulation Method of Use Other |
| nilotinib-hydrochloride (Nilotinib Hydrochloride) | Jan Beumer | Small molecule | 2032-04-07 | 6 patents | Method of Use Other |
| Braftovi (encorafenib) | Pfizer | Small molecule | 2032-11-21 | 5 patents | Formulation Method of Use |
| Infuvite Adult (ASCORBIC ACID) | — | Small molecule | 2032-03-09 | 5 patents | Formulation Method of Use |
| Rexulti (BREXPIPRAZOLE) | Otsuka | Small molecule | 2032-10-12 | 5 patents | Formulation |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2032-02-04 | 5 patents | Formulation Method of Use |
| Advil (ibuprofen) | Generic (originally Boots Group) | Small molecule | 2032-03-16 | 4 patents | Method of Use |
| Aptiom (ESLICARBAZEPINE ACETATE) | Sumitomo Pharma Am | Small molecule | 2032-08-24 | 4 patents | Method of Use |
| Arnicare Leg Cramps (COPPER) | Sebela Womens Hlth | Small molecule | 2032-08-14 | 4 patents | Formulation |
| Cortef (hydrocortisone) | Generic (originally Merck/Upjohn) | Small molecule | 2032-11-19 | 4 patents | Method of Use |
| Inbrija (LEVODOPA) | Merz | Small molecule | 2032-11-16 | 4 patents | Formulation |
| Metro I.V. In Plastic Container (METRONIDAZOLE) | Baxter | Small molecule | 2032-06-28 | 4 patents | Formulation Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2032-02-01 | 4 patents | Formulation |
| Vasotec (ENALAPRIL MALEATE) | Azurity | Small molecule | 2032-11-06 | 4 patents | Formulation Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2032-03-16 | 4 patents | Other |
| Zykadia (ceritinib) | Novartis | Small molecule | 2032-01-18 | 4 patents | Composition of Matter Method of Use |
| Zyprexa (olanzapine) | Eli Lilly | Small molecule | 2032-02-13 | 4 patents | Method of Use |
| chembl-chembl428647 (PACLITAXEL) | — | Small molecule | 2032-03-04 | 4 patents | Method of Use Other |
| fostamatinib-disodium (FOSTAMATINIB DISODIUM) | — | Small molecule | 2032-07-27 | 4 patents | Formulation Method of Use |
| bictegravir-sodium (BICTEGRAVIR SODIUM) | — | Small molecule | 2032-08-15 | 4 patents | Method of Use |
| Calquence (ACALABRUTINIB) | AstraZeneca | Small molecule | 2032-07-11 | 3 patents | Composition of Matter Method of Use |
| Cytarabine (Cytarabine) | Nippon Shinyaku Co., Ltd. | Small molecule | 2032-10-15 | 3 patents | Method of Use |
| Mayzent (SIPONIMOD) | Novartis | Small molecule | 2032-01-05 | 3 patents | Formulation |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2032-07-19 | 3 patents | Method of Use |
| Verquvo (VERICIGUAT) | Merck & Co. | Small molecule | 2032-11-26 | 3 patents | Method of Use |
| Vizimpro (Dacomitinib) | Pfizer Inc. | Small molecule | 2032-09-27 | 3 patents | Composition of Matter |
| fentanyl-citrate (FENTANYL CITRATE) | — | Small molecule | 2032-01-26 | 3 patents | Formulation |
| Aloprim (ALLOPURINOL) | Casper Pharma Llc | Small molecule | 2032-02-29 | 2 patents | Composition of Matter |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2032-06-29 | 2 patents | Formulation Method of Use |
| Dexilant (DEXLANSOPRAZOLE) | Takeda | Small molecule | 2032-03-05 | 2 patents | Method of Use |
| Jascayd (NERANDOMILAST) | Boehringer Ingelheim | Small molecule | 2032-08-23 | 2 patents | Composition of Matter |
| Pifeltro (DORAVIRINE) | Merck & Co. | Small molecule | 2032-08-30 | 2 patents | Method of Use |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2032-03-10 | 2 patents | Composition of Matter |
| Torisel (temsirolimus) | Pfizer | Small molecule | 2032-05-10 | 2 patents | Method of Use Other |
| Trulance (PLECANATIDE) | Salix | Small molecule | 2032-03-01 | 2 patents | Formulation |
| Tukysa (tucatinib) | Seagen | Small molecule | 2032-10-12 | 2 patents | Method of Use |
| Tussionex Pennkinetic (CHLORPHENIRAMINE MALEATE) | Bayer | Small molecule | 2032-01-03 | 2 patents | Formulation Method of Use |
| Ubrelvy (UBROGEPANT) | AbbVie | Small molecule | 2032-07-19 | 2 patents | Method of Use |
| Vocabria (CABOTEGRAVIR) | GSK | Small molecule | 2032-04-13 | 2 patents | Formulation |
| caspofungin-acetate (CASPOFUNGIN ACETATE) | — | Small molecule | 2032-12-21 | 2 patents | Formulation |
| capmatinib-hydrochloride (CAPMATINIB HYDROCHLORIDE) | — | Small molecule | 2032-11-19 | 2 patents | Composition of Matter |
| fingolimod-hydrochloride (FINGOLIMOD HYDROCHLORIDE) | — | Small molecule | 2032-03-30 | 2 patents | Method of Use Other |
| givinostat-hydrochloride (GIVINOSTAT HYDROCHLORIDE) | — | Small molecule | 2032-02-03 | 2 patents | Method of Use |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2032-07-03 | 2 patents | Formulation Method of Use |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2032-01-01 | 2 patents | Formulation |
| tenofovir-alafenamide-fumarate (TENOFOVIR ALAFENAMIDE FUMARATE) | — | Small molecule | 2032-08-15 | 2 patents | Method of Use |
| Asclera (POLIDOCANOL) | Provensis | Small molecule | 2032-05-12 | 1 patents | Formulation |
| Brenzavvy (BEXAGLIFLOZIN) | Theracosbio | Small molecule | 2032-05-14 | 1 patents | Composition of Matter |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2032-05-11 | 1 patents | Formulation |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2032-02-08 | 1 patents | Formulation |
| Gemzar (Gemcitabine Hydrochloride) | Accord Hlthcare | Small molecule | 2032-04-15 | 1 patents | Formulation |
| Inrebic (FEDRATINIB HYDROCHLORIDE) | Bristol-Myers Squibb | Small molecule | 2032-06-04 | 1 patents | Method of Use |
| Kybella (DEOXYCHOLIC ACID) | AbbVie | Small molecule | 2032-02-17 | 1 patents | Method of Use |
| Livtencity (MARIBAVIR) | Takeda | Small molecule | 2032-01-04 | 1 patents | Method of Use |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2032-11-15 | 1 patents | Method of Use |
| Nevanac (NEPAFENAC) | Harrow Health | Small molecule | 2032-03-31 | 1 patents | Formulation |
| Onpattro (PATISIRAN SODIUM) | Alnylam Pharmaceuticals | Small molecule | 2032-08-10 | 1 patents | Method of Use |
| Ravicti (GLYCEROL PHENYLBUTYRATE) | Horizon Therap Us | Small molecule | 2032-03-09 | 1 patents | Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2032-04-16 | 1 patents | Formulation |
| Velcade (bortezomib) | Shilpa | Small molecule | 2032-11-03 | 1 patents | Formulation |
| Zelboraf (vemurafenib) | Hoffmann La Roche | Small molecule | 2032-06-06 | 1 patents | Formulation |
| Zurampic (LESINURAD) | Ironwood Pharms Inc | Small molecule | 2032-02-29 | 1 patents | Composition of Matter |
| bromfenac-sodium (BROMFENAC SODIUM) | — | Small molecule | 2032-11-19 | 1 patents | Formulation |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2032-09-01 | 1 patents | Formulation |
| nitroglycerin (NITROGLYCERIN) | — | Small molecule | 2032-03-11 | 1 patents | Formulation |
| ibuprofen-lysine (IBUPROFEN LYSINE) | — | Small molecule | 2032-03-02 | 1 patents | Composition of Matter |
| chembl-chembl1946170 (REGORAFENIB) | — | Small molecule | 2032-07-09 | 1 patents | Composition of Matter |
| cetirizine-hydrochloride (CETIRIZINE HYDROCHLORIDE) | — | Small molecule | 2032-07-09 | 1 patents | Formulation |
| minocycline-hydrochloride (MINOCYCLINE HYDROCHLORIDE) | — | Small molecule | 2032-10-16 | 1 patents | Formulation |
| atazanavir-sulfate (ATAZANAVIR SULFATE) | — | Small molecule | 2032-10-06 | 1 patents | Formulation |
| alectinib-hydrochloride (ALECTINIB HYDROCHLORIDE) | — | Small molecule | 2032-03-04 | 1 patents | Formulation |
| DANYELZA (NAXITAMAB) | Y-Mabs Therapeutics Inc | Biologic | 2032-11-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| DARZALEX FASPRO (daratumumab-and-hyaluronidase-fihj) | Pfizer | Biologic | 2032-05-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EBANGA (ANSUVIMAB-ZYKL) | RIDGEBACK BIOTHERAPEUTICS | Biologic | 2032-12-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENSPRYNG (SATRALIZUMAB) | GENENTECH | Biologic | 2032-08-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| HULIO (ADALIMUMAB-FKJP) | MYLAN PHARMS INC | Biologic | 2032-07-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| INMAZEB (ATOLTIVIMAB) | Regeneron | Biologic | 2032-10-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LYUMJEV (Insulin Lispro-aabc) | Eli Lilly and Company | Biologic | 2032-06-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MARGENZA (MARGETUXIMAB-CMKB) | MACROGENICS INC | Biologic | 2032-12-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| MONJUVI (TAFASITAMAB-CXIX) | MORPHOSYS US INC | Biologic | 2032-07-31 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NYVEPRIA (Pegfilgrastim-Apgf) | Amgen | Biologic | 2032-06-10 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PHESGO (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) | Genentech, Inc. | Biologic | 2032-06-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| PULMOTECH MAA | CIS BIO INTL | Biologic | 2032-03-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RIABNI (RITUXIMAB-ARRX) | AMGEN INC | Biologic | 2032-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SOGROYA (SOMAPACITAN-BECO) | NOVO NORDISK INC | Biologic | 2032-08-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| Skyrizi (RISANKIZUMAB) | AbbVie | Biologic | 2032-03-02 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TEPEZZA (TEPROTUMUMAB) | Horizon Therapeutics Ireland | Biologic | 2032-01-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TRODELVY (sacituzumab-govitecan) | Immunomedics Inc | Biologic | 2032-04-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| UPLIZNA (INEBILIZUMAB) | Viela Bio | Biologic | 2032-06-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VYEPTI (EPTINEZUMAB-JJMR) | Lundbeck Seattle BioPharmaceuticals, Inc. | Biologic | 2032-02-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | MYLAN PHARMS INC | Biologic | 2032-06-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ENDO GLOBAL AESTHETICS LTD | Biologic | 2032-07-06 | 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.