Patent Cliff Calendar
Drugs losing US patent exclusivity in 2034
116 drugs face loss of exclusivity in 2034 · 92 small-molecule via Orange Book · 24 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.
2034 is long-dated (8 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2034
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Jardiance (empagliflozin) | Boehringer Ingelheim | Small molecule | 2034-04-03 | 201 patents | Method of Use Other |
| Sinemet Cr (CARBIDOPA) | Aton | Small molecule | 2034-10-07 | 64 patents | Formulation Method of Use |
| Imbruvica (ibrutinib) | AbbVie | Small molecule | 2034-02-18 | 30 patents | Method of Use Other |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2034-05-02 | 26 patents | Method of Use |
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2034-03-18 | 23 patents | Other |
| Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) | Innocoll | Small molecule | 2034-03-13 | 20 patents | Formulation Method of Use |
| vadadustat (VADADUSTAT) | — | Small molecule | 2034-06-04 | 18 patents | Composition of Matter Method of Use |
| Ayvakit (AVAPRITINIB) | Blueprint Medicines | Small molecule | 2034-10-15 | 16 patents | Method of Use |
| Elocon (MOMETASONE FUROATE) | Merck & Co. | Small molecule | 2034-03-13 | 16 patents | Formulation Method of Use |
| cysteamine-bitartrate (CYSTEAMINE BITARTRATE) | — | Small molecule | 2034-06-17 | 16 patents | Formulation Other |
| Adempas (RIOCIGUAT) | Bayer | Small molecule | 2034-02-18 | 15 patents | Method of Use |
| Ecclock (SOFPIRONIUM BROMIDE) | Kaken Pharmaceutical | Small molecule | 2034-03-14 | 15 patents | Method of Use |
| chembl-chembl2103744 (MORPHINE SULFATE) | — | Small molecule | 2034-03-12 | 15 patents | Formulation Method of Use |
| Otezla (APREMILAST) | Amgen | Small molecule | 2034-05-29 | 13 patents | Method of Use Other |
| Keppra (levetiracetam) | Generic (originally UCB Pharma) | Small molecule | 2034-03-14 | 12 patents | Formulation Method of Use |
| Palbociclib (palbociclib) | Pfizer Inc. | Small molecule | 2034-02-08 | 12 patents | Composition of Matter Other |
| Parsabiv (ETELCALCETIDE) | Kai Pharms Inc | Small molecule | 2034-06-27 | 12 patents | Formulation Method of Use |
| bosutinib-monohydrate (BOSUTINIB MONOHYDRATE) | — | Small molecule | 2034-02-28 | 10 patents | Method of Use Other |
| Zurzuvae (ZURANOLONE) | Biogen | Small molecule | 2034-04-17 | 9 patents | Composition of Matter Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2034-07-18 | 9 patents | Formulation Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2034-03-08 | 8 patents | Formulation Method of Use |
| Androgel (TESTOSTERONE) | Besins Hlthcare | Small molecule | 2034-02-11 | 8 patents | Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2034-10-06 | 8 patents | Method of Use |
| Xeljanz (Tofacitinib Citrate) | Pfizer | Small molecule | 2034-03-14 | 8 patents | Formulation Method of Use Other |
| Dilaudid-Hp (Hydromorphone Hydrochloride) | Fresenius Kabi | Small molecule | 2034-03-12 | 7 patents | Formulation |
| Xalatan (LATANOPROST) | Thea Pharma | Small molecule | 2034-03-14 | 7 patents | Composition of Matter Formulation Method of Use |
| Amoxil (amoxicillin) | Generic (originally Beecham/GSK) | Small molecule | 2034-02-12 | 6 patents | Formulation Method of Use |
| Arnicare Leg Cramps (COPPER) | Sebela Womens Hlth | Small molecule | 2034-02-24 | 6 patents | Formulation Method of Use |
| Brukinsa (ZANUBRUTINIB) | BeiGene | Small molecule | 2034-04-22 | 6 patents | Method of Use |
| Exondys 51 (ETEPLIRSEN) | Sarepta | Small molecule | 2034-03-14 | 6 patents | Method of Use |
| Mavyret (GLECAPREVIR) | AbbVie | Small molecule | 2034-03-14 | 6 patents | Method of Use Other |
| Voranigo (VORASIDENIB) | Servier | Small molecule | 2034-07-11 | 6 patents | Composition of Matter Method of Use |
| Xarelto (rivaroxaban) | Johnson & Johnson | Small molecule | 2034-02-17 | 6 patents | Method of Use Other |
| chembl-chembl3655081 (ABROCITINIB) | — | Small molecule | 2034-02-19 | 6 patents | Composition of Matter Method of Use |
| tenapanor-hydrochloride (TENAPANOR HYDROCHLORIDE) | — | Small molecule | 2034-04-10 | 6 patents | Method of Use |
| phentolamine-mesylate (PHENTOLAMINE MESYLATE) | — | Small molecule | 2034-01-31 | 6 patents | Formulation |
| testosterone-enanthate (TESTOSTERONE ENANTHATE) | — | Small molecule | 2034-02-11 | 6 patents | Formulation Method of Use |
| Jublia (EFINACONAZOLE) | Bausch Health | Small molecule | 2034-10-02 | 5 patents | Formulation Method of Use |
| Stromectol (ivermectin) | Merck & Co. | Small molecule | 2034-03-13 | 5 patents | Method of Use |
| Ativan (lorazepam) | Generic (originally Wyeth/Pfizer) | Small molecule | 2034-01-08 | 4 patents | Method of Use |
| Aubagio (TERIFLUNOMIDE) | Sanofi | Small molecule | 2034-02-04 | 4 patents | Method of Use Other |
| Camzyos (MAVACAMTEN) | Bristol-Myers Squibb | Small molecule | 2034-06-19 | 4 patents | Method of Use |
| Cortef (hydrocortisone) | Generic (originally Merck/Upjohn) | Small molecule | 2034-05-12 | 4 patents | Method of Use |
| Lasix (furosemide) | Generic (originally Hoechst AG) | Small molecule | 2034-04-03 | 4 patents | Formulation Method of Use |
| Rayaldee (CALCIFEDIOL) | — | Small molecule | 2034-03-14 | 4 patents | Formulation |
| Tembexa (BRINCIDOFOVIR) | Emergent Biodefense | Small molecule | 2034-10-10 | 4 patents | Composition of Matter Formulation Method of Use |
| Trulance (PLECANATIDE) | Salix | Small molecule | 2034-06-05 | 4 patents | Composition of Matter Formulation |
| zoliflodacin (ZOLIFLODACIN) | — | Small molecule | 2034-01-21 | 4 patents | Method of Use |
| elacestrant-hydrochloride (ELACESTRANT HYDROCHLORIDE) | — | Small molecule | 2034-10-10 | 4 patents | Method of Use |
| Alunbrig (brigatinib) | Takeda | Small molecule | 2034-04-10 | 3 patents | Method of Use |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2034-05-23 | 3 patents | Formulation Method of Use |
| Exjade (DEFERASIROX) | Novartis | Small molecule | 2034-11-21 | 3 patents | Composition of Matter |
| Faslodex (fulvestrant) | AstraZeneca | Small molecule | 2034-02-14 | 3 patents | Method of Use |
| Linzess (LINACLOTIDE) | AbbVie | Small molecule | 2034-02-16 | 3 patents | Other |
| Oxbryta (voxelotor) | Global Blood Theraps | Small molecule | 2034-01-29 | 3 patents | Method of Use |
| Pemazyre (PEMIGATINIB) | Incyte Corp | Small molecule | 2034-04-17 | 3 patents | Method of Use |
| Renacidin (CITRIC ACID) | Baxter | Small molecule | 2034-06-23 | 3 patents | Formulation Method of Use |
| Romvimza (VIMSELTINIB) | Deciphera Pharms | Small molecule | 2034-03-14 | 3 patents | Composition of Matter |
| Veozah (FEZOLINETANT) | Astellas Pharma | Small molecule | 2034-03-28 | 3 patents | Method of Use |
| berdazimer-sodium (BERDAZIMER SODIUM) | — | Small molecule | 2034-02-27 | 3 patents | Formulation Method of Use |
| avacincaptad-pegol-sodium (AVACINCAPTAD PEGOL SODIUM) | — | Small molecule | 2034-07-11 | 3 patents | Method of Use |
| ferric-oxyhydroxide (FERRIC OXYHYDROXIDE) | — | Small molecule | 2034-11-26 | 3 patents | Formulation |
| melphalan-hydrochloride (MELPHALAN HYDROCHLORIDE) | — | Small molecule | 2034-01-30 | 3 patents | Formulation |
| Barhemsys (AMISULPRIDE) | Acacia | Small molecule | 2034-02-26 | 2 patents | Method of Use |
| Dificid (FIDAXOMICIN) | Cubist Pharms Llc | Small molecule | 2034-05-28 | 2 patents | Formulation Other |
| Estrace (ESTRADIOL) | Pfizer | Small molecule | 2034-02-02 | 2 patents | Method of Use |
| Gemzar (Gemcitabine Hydrochloride) | Accord Hlthcare | Small molecule | 2034-08-19 | 2 patents | Formulation |
| Jascayd (NERANDOMILAST) | Boehringer Ingelheim | Small molecule | 2034-02-19 | 2 patents | Method of Use |
| Litfulo (Ritlecitinib Tosylate) | Pfizer | Small molecule | 2034-12-03 | 2 patents | Composition of Matter Method of Use |
| Lumigan (BIMATOPROST) | — | Small molecule | 2034-10-31 | 2 patents | Formulation Method of Use |
| Sandimmune (cyclosporine) | Novartis AG (originally Sandoz) | Small molecule | 2034-02-07 | 2 patents | Formulation |
| Welireg (BELZUTIFAN) | Merck & Co. | Small molecule | 2034-09-05 | 2 patents | Method of Use |
| dasiglucagon-hydrochloride (DASIGLUCAGON HYDROCHLORIDE) | — | Small molecule | 2034-01-06 | 2 patents | Method of Use |
| chembl-chembl428647 (PACLITAXEL) | — | Small molecule | 2034-01-12 | 2 patents | Method of Use Other |
| vibegron (VIBEGRON) | — | Small molecule | 2034-03-12 | 2 patents | Composition of Matter Method of Use |
| Colcrys (COLCHICINE) | Scilex Pharms | Small molecule | 2034-05-09 | 1 patents | Method of Use |
| Cytovene (GANCICLOVIR) | Roche Palo | Small molecule | 2034-09-02 | 1 patents | Formulation |
| Jadelle (LEVONORGESTREL) | Fdn Consumer | Small molecule | 2034-03-22 | 1 patents | Method of Use |
| Luzu (LULICONAZOLE) | Bausch Health | Small molecule | 2034-04-28 | 1 patents | Formulation |
| Nurtec Odt (Rimegepant Sulfate) | Pfizer | Small molecule | 2034-02-27 | 1 patents | Method of Use |
| Tavneos (AVACOPAN) | Chemocentryx | Small molecule | 2034-01-06 | 1 patents | Composition of Matter |
| Viltepso (VILTOLARSEN) | Nippon Shinyaku | Small molecule | 2034-04-03 | 1 patents | Composition of Matter |
| Xeglyze (ABAMETAPIR) | Hatchtech | Small molecule | 2034-12-17 | 1 patents | Method of Use |
| isopropyl-alcohol (ISOPROPYL ALCOHOL) | — | Small molecule | 2034-12-20 | 1 patents | Method of Use |
| rizatriptan-benzoate (RIZATRIPTAN BENZOATE) | — | Small molecule | 2034-07-30 | 1 patents | Composition of Matter |
| chembl-chembl34259 (METHOTREXATE) | — | Small molecule | 2034-10-29 | 1 patents | Method of Use |
| chembl-chembl1444 (LETROZOLE) | — | Small molecule | 2034-08-07 | 1 patents | Method of Use |
| chembl-chembl1200962 (CEFEPIME HYDROCHLORIDE) | — | Small molecule | 2034-11-07 | 1 patents | Method of Use |
| lutetium-lu-177-vipivotide-tetraxetan (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) | — | Small molecule | 2034-10-17 | 1 patents | Composition of Matter |
| triheptanoin (TRIHEPTANOIN) | — | Small molecule | 2034-11-14 | 1 patents | Formulation |
| nusinersen-sodium (NUSINERSEN SODIUM) | — | Small molecule | 2034-01-09 | 1 patents | Method of Use |
| esketamine-hydrochloride (ESKETAMINE HYDROCHLORIDE) | — | Small molecule | 2034-03-14 | 1 patents | Method of Use |
| ALYMSYS (BEVACIZUMAB-MALY) | AMNEAL PHARMS LLC | Biologic | 2034-04-13 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| BRIUMVI (UBLITUXIMAB-XIIY) | TG THERAPEUTICS, INC | Biologic | 2034-12-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| CIMERLI (RANIBIZUMAB-EQRN) | SANDOZ INC | Biologic | 2034-08-02 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| DAXXIFY (DAXIBOTULINUMTOXINA-LANM) | REVANCE THERAPEUTICS, INC. | Biologic | 2034-09-07 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ELAHERE | IMMUNOGEN INC | Biologic | 2034-11-14 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ENJAYMO (SUTIMLIMAB) | Bioverativ Therapeutics Inc | Biologic | 2034-02-04 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| FYLNETRA (PEGFILGRASTIM-PBBK) | KASHIV BIOSCIENCES LLC | Biologic | 2034-05-26 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| IMJUDO (TREMELIMUMAB-ACTL) | ASTRAZENECA AB | Biologic | 2034-10-21 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| KIMMTRAK (TEBENTAFUSP) | IMMUNOCORE LTD | Biologic | 2034-01-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| LUNSUMIO (MOSUNETUZUMAB-AXGB) | GENENTECH INC | Biologic | 2034-12-22 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| NEXOBRID (anacaulase) | Mediwound, Ltd | Biologic | 2034-12-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| OPDUALAG (RELATLIMAB-RMBW) | BRISTOL MYERS SQUIBB | Biologic | 2034-03-18 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| RELEUKO (FILGRASTIM-AYOW) | KASHIV BIOSCIENCES LLC | Biologic | 2034-02-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| REZVOGLAR KWIKPEN | ELI LILLY CO | Biologic | 2034-11-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| ROLVEDON (EFLAPEGRASTIM) | Spectrum Pharms | Biologic | 2034-09-09 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SKYRIZI (RISANKIZUMAB) | AbbVie | Biologic | 2034-06-16 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| SPEVIGO (SPESOLIMAB) | Boehringer Ingelheim Pharmaceuticals Inc | Biologic | 2034-09-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| STIMUFEND (PEGFILGRASTIM-FPGK) | FRESENIUS KABI USA | Biologic | 2034-09-01 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TECVAYLI (TECLISTAMAB-CQYV) | JANSSEN BIOTECH | Biologic | 2034-10-25 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| TZIELD (TEPLIZUMAB) | Provention Bio Inc | Biologic | 2034-11-17 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VABYSMO (FARICIMAB) | Roche | Biologic | 2034-01-28 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| VEGZELMA (BEVACIZUMAB-ADCD) | CELLTRION | Biologic | 2034-09-27 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| XENPOZYME (OLIPUDASE ALFA-RPCP) | GENZYME CORP | Biologic | 2034-08-31 | BPCIA 12-yr exclusivity | BPCIA Biologic Exclusivity |
| (unknown) | ASTRAZENECA AB | Biologic | 2034-11-10 | 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.