Patent Cliff Calendar
Drugs losing US patent exclusivity in 2033
131 drugs face loss of exclusivity in 2033 · 111 small-molecule via Orange Book · 20 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.
2033 is long-dated (7 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2033
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2033-06-03 | 81 patents | Composition of Matter Formulation Method of Use Other |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2033-02-27 | 54 patents | Formulation Method of Use Other |
| Vascepa (ICOSAPENT ETHYL) | Amarin Pharms | Small molecule | 2033-06-28 | 46 patents | Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2033-04-23 | 33 patents | Formulation Method of Use |
| Lotemax (LOTEPREDNOL ETABONATE) | Bausch Health | Small molecule | 2033-05-03 | 30 patents | Formulation Method of Use |
| Topamax (topiramate) | Janssen | Small molecule | 2033-03-19 | 25 patents | Formulation Method of Use |
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2033-09-18 | 23 patents | Formulation Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2033-03-15 | 21 patents | Formulation Method of Use |
| Saphris (ASENAPINE) | Hisamitsu | Small molecule | 2033-07-25 | 18 patents | Formulation Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2033-08-22 | 17 patents | Method of Use |
| Aristada (ARIPIPRAZOLE LAUROXIL) | Alkermes Inc | Small molecule | 2033-09-19 | 16 patents | Formulation Method of Use |
| Viberzi (ELUXADOLINE) | AbbVie | Small molecule | 2033-03-14 | 16 patents | Formulation Method of Use |
| ponatinib-hydrochloride (PONATINIB HYDROCHLORIDE) | — | Small molecule | 2033-12-12 | 16 patents | Method of Use |
| Venclexta (venetoclax) | AbbVie | Small molecule | 2033-09-06 | 15 patents | Method of Use |
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2033-04-22 | 12 patents | Method of Use Other |
| resmetirom (RESMETIROM) | — | Small molecule | 2033-09-17 | 12 patents | Composition of Matter Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2033-06-04 | 10 patents | Method of Use |
| Gemzar (Gemcitabine Hydrochloride) | Accord Hlthcare | Small molecule | 2033-07-01 | 10 patents | Formulation |
| Taxotere (Docetaxel) | Sanofi | Small molecule | 2033-09-30 | 9 patents | Formulation Method of Use |
| bendamustine-hydrochloride (BENDAMUSTINE HYDROCHLORIDE) | — | Small molecule | 2033-03-15 | 9 patents | Method of Use |
| Camptosar (Irinotecan Hydrochloride) | Pfizer | Small molecule | 2033-06-12 | 8 patents | Method of Use |
| Zetia (EZETIMIBE) | Merck & Co. | Small molecule | 2033-05-01 | 8 patents | Method of Use |
| bictegravir-sodium (BICTEGRAVIR SODIUM) | — | Small molecule | 2033-02-15 | 8 patents | Composition of Matter Other |
| dextroamphetamine (DEXTROAMPHETAMINE) | — | Small molecule | 2033-10-24 | 8 patents | Formulation Method of Use |
| Emtriva (EMTRICITABINE) | Gilead Sciences | Small molecule | 2033-01-14 | 7 patents | Formulation Other |
| Piqray (alpelisib) | Novartis | Small molecule | 2033-04-29 | 7 patents | Composition of Matter Method of Use |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2033-04-05 | 7 patents | Formulation |
| methotrexate-sodium (METHOTREXATE SODIUM) | — | Small molecule | 2033-01-02 | 7 patents | Formulation Method of Use |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2033-03-15 | 6 patents | Method of Use |
| Infuvite Adult (ASCORBIC ACID) | — | Small molecule | 2033-09-10 | 6 patents | Formulation Method of Use |
| Kyprolis (carfilzomib) | Amgen | Small molecule | 2033-02-27 | 6 patents | Formulation Other |
| Ocaliva (OBETICHOLIC ACID) | Intercept Pharms Inc | Small molecule | 2033-06-17 | 6 patents | Composition of Matter Formulation Method of Use |
| Tybost (COBICISTAT) | Gilead Sciences | Small molecule | 2033-02-15 | 6 patents | Other |
| viloxazine-hydrochloride (VILOXAZINE HYDROCHLORIDE) | — | Small molecule | 2033-02-07 | 6 patents | Formulation Method of Use |
| chembl-chembl2103744 (MORPHINE SULFATE) | — | Small molecule | 2033-07-01 | 6 patents | Method of Use |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2033-06-04 | 6 patents | Method of Use |
| Rexulti (BREXPIPRAZOLE) | Otsuka | Small molecule | 2033-04-12 | 5 patents | Other |
| Sporanox (itraconazole) | Sebela Ireland Ltd | Small molecule | 2033-06-21 | 5 patents | Formulation Method of Use |
| Xtandi (enzalutamide) | Astellas Pharma | Small molecule | 2033-09-11 | 5 patents | Formulation Method of Use |
| Cortef (hydrocortisone) | Generic (originally Merck/Upjohn) | Small molecule | 2033-01-10 | 4 patents | Method of Use |
| Cubicin (Daptomycin) | Baxter | Small molecule | 2033-09-11 | 4 patents | Method of Use |
| Renacidin (CITRIC ACID) | Baxter | Small molecule | 2033-03-15 | 4 patents | Composition of Matter Method of Use |
| Rinvoq (upadacitinib) | AbbVie Inc. | Small molecule | 2033-08-16 | 4 patents | Composition of Matter |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2033-05-22 | 4 patents | Composition of Matter Method of Use |
| Tibsovo (IVOSIDENIB) | Servier | Small molecule | 2033-01-18 | 4 patents | Method of Use |
| Tradjenta (LINAGLIPTIN) | Boehringer Ingelheim | Small molecule | 2033-03-06 | 4 patents | Method of Use Other |
| Viagra (Sildenafil Citrate) | Pfizer Inc. | Small molecule | 2033-12-16 | 4 patents | Formulation |
| Wayrilz (RILZABRUTINIB) | Genzyme Corp | Small molecule | 2033-03-01 | 4 patents | Composition of Matter Method of Use |
| Zyprexa (olanzapine) | Eli Lilly | Small molecule | 2033-05-31 | 4 patents | Method of Use |
| pexidartinib-hydrochloride (PEXIDARTINIB HYDROCHLORIDE) | — | Small molecule | 2033-05-04 | 4 patents | Composition of Matter Method of Use |
| esmolol-hydrochloride (ESMOLOL HYDROCHLORIDE) | — | Small molecule | 2033-03-15 | 4 patents | Formulation |
| imetelstat-sodium (IMETELSTAT SODIUM) | — | Small molecule | 2033-03-15 | 4 patents | Method of Use |
| sodium-phenylbutyrate (SODIUM PHENYLBUTYRATE) | — | Small molecule | 2033-12-24 | 4 patents | Formulation Method of Use |
| tenapanor-hydrochloride (TENAPANOR HYDROCHLORIDE) | — | Small molecule | 2033-08-01 | 4 patents | Composition of Matter |
| Balversa (ERDAFITINIB) | Johnson & Johnson | Small molecule | 2033-04-12 | 3 patents | Composition of Matter |
| Cytarabine (Cytarabine) | Nippon Shinyaku Co., Ltd. | Small molecule | 2033-04-15 | 3 patents | Other |
| Epanova (OMEGA-3-CARBOXYLIC ACIDS) | AstraZeneca | Small molecule | 2033-01-04 | 3 patents | Composition of Matter Method of Use |
| Kerendia (FINERENONE) | Bayer | Small molecule | 2033-08-26 | 3 patents | Composition of Matter |
| Linzess (LINACLOTIDE) | AbbVie | Small molecule | 2033-08-16 | 3 patents | Method of Use |
| Luzu (LULICONAZOLE) | Bausch Health | Small molecule | 2033-09-06 | 3 patents | Composition of Matter Method of Use |
| Mektovi (binimetinib) | Pfizer | Small molecule | 2033-10-18 | 3 patents | Composition of Matter Method of Use |
| Miebo (PERFLUOROHEXYLOCTANE) | Bausch Health | Small molecule | 2033-09-12 | 3 patents | Method of Use |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2033-11-25 | 3 patents | Composition of Matter |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2033-03-13 | 3 patents | Composition of Matter |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2033-08-23 | 3 patents | Formulation Method of Use |
| Sotyktu (DEUCRAVACITINIB) | Bristol-Myers Squibb | Small molecule | 2033-11-07 | 3 patents | Composition of Matter Method of Use |
| Vumerity (DIROXIMEL FUMARATE) | Biogen | Small molecule | 2033-09-20 | 3 patents | Composition of Matter Method of Use |
| Zavesca (MIGLUSTAT) | AstraZeneca | Small molecule | 2033-03-07 | 3 patents | Method of Use |
| cabozantinib-s-malate (CABOZANTINIB S-MALATE) | — | Small molecule | 2033-07-09 | 3 patents | Formulation |
| Arnicare Leg Cramps (COPPER) | Sebela Womens Hlth | Small molecule | 2033-04-09 | 2 patents | Formulation |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2033-09-27 | 2 patents | Composition of Matter |
| Evrysdi (RISDIPLAM) | Roche | Small molecule | 2033-02-08 | 2 patents | Composition of Matter |
| Jadelle (LEVONORGESTREL) | Fdn Consumer | Small molecule | 2033-10-06 | 2 patents | Composition of Matter Method of Use |
| Lorbrena (lorlatinib) | Pfizer | Small molecule | 2033-03-05 | 2 patents | Composition of Matter |
| Lytgobi (futibatinib) | Taiho Oncology | Small molecule | 2033-02-13 | 2 patents | Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2033-03-31 | 2 patents | Formulation |
| Orgovyx (relugolix) | MYOVANT SCIENCES | Small molecule | 2033-09-27 | 2 patents | Composition of Matter |
| Prevymis (LETERMOVIR) | Merck & Co. | Small molecule | 2033-02-28 | 2 patents | Formulation |
| Skyclarys (OMAVELOXOLONE) | Biogen Us | Small molecule | 2033-04-24 | 2 patents | Composition of Matter |
| Tukysa (tucatinib) | Seagen | Small molecule | 2033-03-25 | 2 patents | Method of Use |
| Ubrelvy (UBROGEPANT) | AbbVie | Small molecule | 2033-12-23 | 2 patents | Composition of Matter |
| Xiidra (LIFITEGRAST) | Bausch Health | Small molecule | 2033-07-25 | 2 patents | Formulation |
| Zulresso (BREXANOLONE) | Sage Therap | Small molecule | 2033-01-23 | 2 patents | Formulation Method of Use |
| tenofovir-alafenamide-fumarate (TENOFOVIR ALAFENAMIDE FUMARATE) | — | Small molecule | 2033-02-15 | 2 patents | Other |
| trifarotene (TRIFAROTENE) | — | Small molecule | 2033-05-30 | 2 patents | Method of Use |
| torsemide (TORSEMIDE) | — | Small molecule | 2033-10-06 | 2 patents | Formulation |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2033-01-16 | 2 patents | Formulation |
| durlobactam-sodium (DURLOBACTAM SODIUM) | — | Small molecule | 2033-04-02 | 2 patents | Composition of Matter Method of Use |
| Aczone (DAPSONE) | Almirall | Small molecule | 2033-11-18 | 1 patents | Formulation |
| Agamree (VAMOROLONE) | Catalyst Pharms | Small molecule | 2033-03-07 | 1 patents | Method of Use |
| Braftovi (encorafenib) | Pfizer | Small molecule | 2033-08-05 | 1 patents | Method of Use |
| Bupivacaine Hydrochloride And Epinephrine (Bupivacaine Hydrochloride) | Pfizer | Small molecule | 2033-01-09 | 1 patents | Formulation |
| Inbrija (LEVODOPA) | Merz | Small molecule | 2033-10-21 | 1 patents | Method of Use |
| Kengreal (CANGRELOR) | Chiesi | Small molecule | 2033-03-09 | 1 patents | Method of Use |
| Mifeprex (MIFEPRISTONE) | Corcept Therap | Small molecule | 2033-03-05 | 1 patents | Method of Use |
| Natroba (SPINOSAD) | Cipher | Small molecule | 2033-11-25 | 1 patents | Method of Use |
| Nubeqa (darolutamide) | Bayer | Small molecule | 2033-03-25 | 1 patents | Method of Use |
| Nurtec Odt (Rimegepant Sulfate) | Pfizer | Small molecule | 2033-02-25 | 1 patents | Composition of Matter |
| Picato (INGENOL MEBUTATE) | Leo Labs | Small molecule | 2033-05-15 | 1 patents | Method of Use |
| Scenesse (AFAMELANOTIDE) | Clivunel Inc | Small molecule | 2033-01-20 | 1 patents | Method of Use |
| Tegretol (carbamazepine) | Novartis AG (originally Geigy) | Small molecule | 2033-02-27 | 1 patents | Formulation |
| Tricor (Micronized) (FENOFIBRATE) | Salix | Small molecule | 2033-05-31 | 1 patents | Method of Use |
| Tygacil (TIGECYCLINE) | Fresenius Kabi | Small molecule | 2033-04-07 | 1 patents | Formulation |
| Vivjoa (OTESECONAZOLE) | Mycovia Pharms | Small molecule | 2033-05-09 | 1 patents | Method of Use |
| Xtoro (FINAFLOXACIN) | Fonseca Biosciences | Small molecule | 2033-11-21 | 1 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2033-05-16 | 1 patents | Formulation |
| posaconazole (POSACONAZOLE) | — | Small molecule | 2033-02-27 | 1 patents | Formulation |
| cetirizine-hydrochloride (CETIRIZINE HYDROCHLORIDE) | — | Small molecule | 2033-01-09 | 1 patents | Other |
| esketamine-hydrochloride (ESKETAMINE HYDROCHLORIDE) | — | Small molecule | 2033-03-05 | 1 patents | Method of Use |
| nitisinone (NITISINONE) | — | Small molecule | 2033-02-28 | 1 patents | Method of Use |
| bromfenac-sodium (BROMFENAC SODIUM) | — | Small molecule | 2033-11-11 | 1 patents | Method of Use |
| ADBRY (TRALOKINUMAB) | Leo Pharma As | Biologic | 2033-12-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BESREMI (ROPEGINTERFERON ALFA-2B) | Pharma Essentia Corporation | Biologic | 2033-11-12 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BYOOVIZ (RANIBIZUMAB-NUNA) | SAMSUNG BIOEPIS CO LTD | Biologic | 2033-09-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EVKEEZA (EVINACUMAB-DGNB) | REGENERON PHARMACEUTICALS | Biologic | 2033-02-11 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| INSULIN GLARGINE | MYLAN PHARMS INC | Biologic | 2033-07-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| JEMPERLI (DOSTARLIMAB-GXLY) | GLAXOSMITHKLINE | Biologic | 2033-04-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NEXVIAZYME (AVALGLUCOSIDASE ALFA-NGPT) | GENZYME CORP | Biologic | 2033-08-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| REPATHA (EVOLOCUMAB) | Repatha | Biologic | 2033-02-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYBREVANT (AMIVANTAMAB-VMJW) | JANSSEN BIOTECH | Biologic | 2033-05-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYLAZE | JAZZ PHARMS | Biologic | 2033-06-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SAPHNELO (ANIFROLUMAB) | AstraZeneca | Biologic | 2033-07-30 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SKYTROFA (LONAPEGSOMATROPIN-TCGD) | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S | Biologic | 2033-08-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SUSVIMO | GENENTECH INC | Biologic | 2033-10-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TEZSPIRE (AMG 157) | AstraZeneca | Biologic | 2033-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TIVDAK (tisotumab-vedotin) | SEAGEN | Biologic | 2033-09-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VYVGART (EFGARTIGIMOD ALFA) | Argenx Bv | Biologic | 2033-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| YUSIMRY (ADALIMUMAB-AQVH) | COHERUS BIOSCIENCES INC | Biologic | 2033-12-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZYNLONTA (LONCASTUXIMAB TESIRINE) | ADC Therapeutics SA | Biologic | 2033-04-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | BIOGEN INC | Biologic | 2033-06-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | GLAXOSMITHKLINE LLC | Biologic | 2033-08-17 | 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.