Patent Cliff Calendar
Drugs losing US patent exclusivity in 2035
122 drugs face loss of exclusivity in 2035 · 93 small-molecule via Orange Book · 29 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.
2035 is long-dated (9 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2035
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| vasopressin (VASOPRESSIN) | — | Small molecule | 2035-01-30 | 47 patents | Formulation Method of Use |
| Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) | Innocoll | Small molecule | 2035-04-20 | 40 patents | Formulation Method of Use |
| Emend (APREPITANT) | Merck & Co. | Small molecule | 2035-09-18 | 27 patents | Formulation Method of Use |
| Epidiolex (CANNABIDIOL) | Jazz Pharms Res | Small molecule | 2035-06-17 | 27 patents | Formulation Method of Use |
| Brinsupri (BRENSOCATIB) | Insmed Inc | Small molecule | 2035-01-21 | 24 patents | Composition of Matter Method of Use |
| Aristada (ARIPIPRAZOLE LAUROXIL) | Alkermes Inc | Small molecule | 2035-03-19 | 22 patents | Formulation Method of Use |
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2035-04-24 | 19 patents | Other |
| Tecfidera (DIMETHYL FUMARATE) | Biogen | Small molecule | 2035-03-13 | 16 patents | Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2035-04-06 | 15 patents | Formulation Other |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2035-02-19 | 15 patents | Formulation Method of Use |
| Ubrelvy (UBROGEPANT) | AbbVie | Small molecule | 2035-01-30 | 14 patents | Formulation |
| Accutane (ISOTRETINOIN) | — | Small molecule | 2035-05-29 | 12 patents | Formulation |
| Crenessity (CRINECERFONT) | Neurocrine | Small molecule | 2035-01-21 | 12 patents | Method of Use |
| Zestril (lisinopril) | Generic (originally Merck/AstraZeneca) | Small molecule | 2035-11-06 | 12 patents | Formulation Method of Use |
| diazoxide-choline (DIAZOXIDE CHOLINE) | — | Small molecule | 2035-11-12 | 12 patents | Method of Use |
| Solosec (SECNIDAZOLE) | Evofem Inc | Small molecule | 2035-09-04 | 10 patents | Method of Use |
| varenicline-tartrate (VARENICLINE TARTRATE) | — | Small molecule | 2035-10-19 | 10 patents | Formulation Method of Use |
| Cytoxan (Lyophilized) (cyclophosphamide) | Baxter | Small molecule | 2035-06-26 | 9 patents | Formulation |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2035-02-06 | 9 patents | Composition of Matter Formulation Method of Use |
| Inlyta (Axitinib) | Pfizer | Small molecule | 2035-02-03 | 8 patents | Method of Use Other |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2035-05-08 | 8 patents | Composition of Matter Other |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2035-03-13 | 7 patents | Formulation Method of Use |
| Balversa (ERDAFITINIB) | Johnson & Johnson | Small molecule | 2035-03-26 | 6 patents | Formulation Method of Use |
| Dayvigo (LEMBOREXANT) | Eisai | Small molecule | 2035-10-21 | 6 patents | Formulation Method of Use |
| Levophed (Norepinephrine Bitartrate) | Pfizer Inc. | Small molecule | 2035-02-26 | 6 patents | Formulation |
| Ekterly (SEBETRALSTAT) | Kalvista | Small molecule | 2035-11-26 | 5 patents | Composition of Matter Method of Use |
| Remodulin (TREPROSTINIL) | United Therap | Small molecule | 2035-04-01 | 5 patents | Formulation |
| Rezlidhia (OLUTASIDENIB) | Rigel Pharms | Small molecule | 2035-09-18 | 5 patents | Formulation Method of Use |
| Vancocin (vancomycin) | ANI Pharmaceuticals | Small molecule | 2035-11-06 | 5 patents | Formulation Method of Use |
| Akynzeo (NETUPITANT) | Helsinn Hlthcare | Small molecule | 2035-09-25 | 4 patents | Composition of Matter |
| Kengreal (CANGRELOR) | Chiesi | Small molecule | 2035-07-10 | 4 patents | Formulation Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2035-03-31 | 4 patents | Formulation Method of Use |
| Rozlytrek (entrectinib) | Roche | Small molecule | 2035-02-17 | 4 patents | Method of Use |
| Subutex (BUPRENORPHINE) | Purdue Pharma Lp | Small molecule | 2035-11-06 | 4 patents | Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2035-10-29 | 4 patents | Composition of Matter |
| capmatinib-hydrochloride (CAPMATINIB HYDROCHLORIDE) | — | Small molecule | 2035-07-22 | 4 patents | Formulation |
| perflutren (PERFLUTREN) | — | Small molecule | 2035-12-28 | 4 patents | Composition of Matter Method of Use |
| bictegravir-sodium (BICTEGRAVIR SODIUM) | — | Small molecule | 2035-06-19 | 4 patents | Composition of Matter Method of Use |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2035-07-10 | 4 patents | Method of Use |
| Alunbrig (brigatinib) | Takeda | Small molecule | 2035-11-10 | 3 patents | Method of Use |
| Brexafemme (IBREXAFUNGERP CITRATE) | GSK | Small molecule | 2035-01-19 | 3 patents | Composition of Matter Method of Use |
| Calquence (ACALABRUTINIB) | AstraZeneca | Small molecule | 2035-01-21 | 3 patents | Method of Use |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2035-02-19 | 3 patents | Formulation Method of Use Other |
| Januvia (SITAGLIPTIN) | Zydus Lifesciences | Small molecule | 2035-02-25 | 3 patents | Formulation |
| Kalydeco (IVACAFTOR) | Vertex Pharms Inc | Small molecule | 2035-04-14 | 3 patents | Method of Use |
| Kerendia (FINERENONE) | Bayer | Small molecule | 2035-07-29 | 3 patents | Composition of Matter |
| Mucinex (guaifenesin) | Generic (multiple manufacturers) | Small molecule | 2035-11-13 | 3 patents | Method of Use |
| Pemazyre (PEMIGATINIB) | Incyte Corp | Small molecule | 2035-01-30 | 3 patents | Composition of Matter |
| Qalsody (TOFERSEN) | Biogen Ma | Small molecule | 2035-04-01 | 3 patents | Composition of Matter Method of Use |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2035-01-30 | 3 patents | Formulation |
| Scemblix (ASCIMINIB HYDROCHLORIDE) | Novartis | Small molecule | 2035-10-29 | 3 patents | Method of Use |
| Subutex (Buprenorphine Hydrochloride) | Indivior | Small molecule | 2035-04-24 | 3 patents | Formulation |
| Tibsovo (IVOSIDENIB) | Servier | Small molecule | 2035-03-13 | 3 patents | Formulation Method of Use |
| Zavesca (MIGLUSTAT) | AstraZeneca | Small molecule | 2035-09-30 | 3 patents | Method of Use |
| viloxazine-hydrochloride (VILOXAZINE HYDROCHLORIDE) | — | Small molecule | 2035-04-02 | 3 patents | Formulation |
| pemetrexed-disodium (PEMETREXED DISODIUM) | — | Small molecule | 2035-03-26 | 3 patents | Formulation |
| foscarbidopa (FOSCARBIDOPA) | AbbVie GK | Small molecule | 2035-10-21 | 3 patents | Composition of Matter Method of Use |
| esketamine-hydrochloride (ESKETAMINE HYDROCHLORIDE) | — | Small molecule | 2035-09-10 | 3 patents | Method of Use |
| ferric-oxyhydroxide (FERRIC OXYHYDROXIDE) | — | Small molecule | 2035-05-26 | 3 patents | Other |
| nitisinone (NITISINONE) | — | Small molecule | 2035-01-05 | 3 patents | Method of Use |
| Accrufer (FERRIC MALTOL) | Shield Tx | Small molecule | 2035-01-06 | 2 patents | Method of Use |
| Augtyro (REPOTRECTINIB) | Bristol | Small molecule | 2035-01-23 | 2 patents | Composition of Matter |
| Copiktra (DUVELISIB) | Secura | Small molecule | 2035-04-26 | 2 patents | Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2035-12-03 | 2 patents | Formulation |
| Evrysdi (RISDIPLAM) | Roche | Small molecule | 2035-05-11 | 2 patents | Method of Use |
| Lignospan Forte (Lidocaine Hydrochloride) | Fresenius Kabi | Small molecule | 2035-04-27 | 2 patents | Method of Use |
| Ohtuvayre (ENSIFENTRINE) | Verona Pharma | Small molecule | 2035-09-15 | 2 patents | Formulation Method of Use |
| Ojemda (TOVORAFENIB) | Day One Biopharms | Small molecule | 2035-06-23 | 2 patents | Formulation |
| Voranigo (VORASIDENIB) | Servier | Small molecule | 2035-12-04 | 2 patents | Method of Use |
| dasiglucagon-hydrochloride (DASIGLUCAGON HYDROCHLORIDE) | — | Small molecule | 2035-02-03 | 2 patents | Composition of Matter |
| lazertinib-mesylate (LAZERTINIB MESYLATE) | — | Small molecule | 2035-10-13 | 2 patents | Method of Use |
| durlobactam-sodium (DURLOBACTAM SODIUM) | — | Small molecule | 2035-11-17 | 2 patents | Method of Use |
| alectinib-hydrochloride (ALECTINIB HYDROCHLORIDE) | — | Small molecule | 2035-04-24 | 2 patents | Formulation |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2035-07-17 | 2 patents | Formulation Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2035-03-20 | 2 patents | Method of Use |
| danicopan (DANICOPAN) | — | Small molecule | 2035-02-25 | 2 patents | Method of Use |
| Cipro (Ciprofloxacin) | Alk Abello | Small molecule | 2035-07-01 | 1 patents | Formulation |
| Exem Foam Kit (AIR POLYMER-TYPE A) | Giskit | Small molecule | 2035-05-04 | 1 patents | Method of Use |
| Jublia (EFINACONAZOLE) | Bausch Health | Small molecule | 2035-04-25 | 1 patents | Method of Use |
| Miebo (PERFLUOROHEXYLOCTANE) | Bausch Health | Small molecule | 2035-10-01 | 1 patents | Method of Use |
| Onpattro (PATISIRAN SODIUM) | Alnylam Pharmaceuticals | Small molecule | 2035-08-27 | 1 patents | Method of Use |
| Spy Agent Green Kit (INDOCYANINE GREEN) | Renew Pharms | Small molecule | 2035-08-04 | 1 patents | Method of Use |
| Temovate (CLOBETASOL PROPIONATE) | Fougera Pharms | Small molecule | 2035-03-11 | 1 patents | Formulation |
| Unithroid (LEVOTHYROXINE SODIUM) | Fresenius Kabi | Small molecule | 2035-02-27 | 1 patents | Formulation |
| Vyndaqel (tafamidis) | Foldrx Pharms | Small molecule | 2035-08-31 | 1 patents | Method of Use |
| Ycanth (CANTHARIDIN) | Verrica Pharms | Small molecule | 2035-05-28 | 1 patents | Method of Use |
| glycopyrrolate (Glycopyrrolate) | Yonsei University | Small molecule | 2035-09-14 | 1 patents | Formulation |
| chembl-chembl225072 (PEMETREXED) | — | Small molecule | 2035-10-28 | 1 patents | Composition of Matter |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2035-10-28 | 1 patents | Formulation |
| nusinersen-sodium (NUSINERSEN SODIUM) | — | Small molecule | 2035-09-11 | 1 patents | Method of Use |
| metformin-hydrochloride (METFORMIN HYDROCHLORIDE) | — | Small molecule | 2035-05-01 | 1 patents | Formulation |
| lutetium-lu-177-vipivotide-tetraxetan (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) | — | Small molecule | 2035-11-12 | 1 patents | Method of Use |
| sevabertinib (SEVABERTINIB) | — | Small molecule | 2035-10-10 | 1 patents | Composition of Matter |
| ADALIMUMAB (ADALIMUMAB-AATY) | CELLTRION | Biologic | 2035-05-23 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| AVZIVI TNJN (bevacizumab) | Roche | Biologic | 2035-12-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BEYFORTUS (NIRSEVIMAB-ALIP) | ASTRAZENECA AB | Biologic | 2035-07-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BIMZELX (BIMEKIZUMAB-BKZX) | UCB INC | Biologic | 2035-10-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| COLUMVI (GLOFITAMAB-GXBM) | GENENTECH INC | Biologic | 2035-06-15 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| COSENTYX (secukinumab) | Novartis | Biologic | 2035-10-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ELFABRIO (PEGUNIGALSIDASE ALFA-IWXJ) | CHIESI FARMACEUTICI SPA | Biologic | 2035-05-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ELREXFIO (elranatamab) | Pfizer | Biologic | 2035-08-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENTYVIO (vedolizumab) | Takeda | Biologic | 2035-09-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EPKINLY (EPCORITAMAB) | Genmab Us, Inc. | Biologic | 2035-05-19 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| EYLEA HD (AFLIBERCEPT) | Regeneron | Biologic | 2035-08-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LAMZEDE | CHIESI FARMACEUTICI SPA | Biologic | 2035-02-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LEQEMBI (LECANEMAB-IRMB) | EISAI INC | Biologic | 2035-01-06 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LOQTORZI (TORIPALIMAB) | Coherus Biosciences Inc | Biologic | 2035-10-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NGENLA (somatrogon) | Pfizer Ireland Pharmaceuticals | Biologic | 2035-06-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OMVOH (MIRIKIZUMAB-MRKZ) | ELI LILLY AND CO | Biologic | 2035-10-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| POMBILITI ATGA (CIPAGLUCOSIDASE ALFA-ATGA) | AMICUS THERAP US | Biologic | 2035-09-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYSTIGGO (ROZANOLIXIZUMAB-NOLI) | UCB INC | Biologic | 2035-06-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RYZNEUTA (EFBEMALENOGRASTIM ALFA-VUXW) | EVIVE BIOTECHNOLOGY | Biologic | 2035-11-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TALVEY (TALQUETAMAB) | Janssen Biotech | Biologic | 2035-08-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TOFIDENCE (TOCILIZUMAB-BAVI) | BIOGEN MA | Biologic | 2035-09-29 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TYRUKO (NATALIZUMAB-SZTN) | SANDOZ INC | Biologic | 2035-08-24 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VEOPOZ (POZELIMAB) | Regeneron | Biologic | 2035-08-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VYVGART HYTRULO | ARGENX BV | Biologic | 2035-06-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| WEZLANA (USTEKINUMAB-AUUB) | AMGEN INC | Biologic | 2035-10-31 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| WEZLANA (USTEKINUMAB-AUUB) | AMGEN INC | Biologic | 2035-10-31 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZYMFENTRA (Infliximab-Dyyb) | Asan Medical Center | Biologic | 2035-10-20 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ZYNYZ (RETIFANLIMAB-DLWR) | INCYTE CORP | Biologic | 2035-03-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | HALOZYME THERAP | Biologic | 2035-06-20 | 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.