Patent Cliff Calendar
Drugs losing US patent exclusivity in 2041
59 drugs face loss of exclusivity in 2041 · 59 small-molecule via Orange Book
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.
2041 is long-dated (15 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2041
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Sinemet Cr (CARBIDOPA) | Aton | Small molecule | 2041-12-21 | 52 patents | Method of Use |
| Sprycel (dasatinib) | Handa Therap | Small molecule | 2041-01-22 | 36 patents | Formulation Method of Use |
| mirdametinib (MIRDAMETINIB) | — | Small molecule | 2041-02-17 | 31 patents | Composition of Matter Formulation Method of Use |
| Bupivacaine Hydrochloride And Epinephrine (BUPIVACAINE) | Innocoll | Small molecule | 2041-01-12 | 30 patents | Formulation Method of Use |
| Mounjaro (TIRZEPATIDE) | Eli Lilly | Small molecule | 2041-12-30 | 24 patents | Method of Use |
| cupric-sulfate (CUPRIC SULFATE) | — | Small molecule | 2041-07-01 | 15 patents | Formulation Method of Use |
| chembl-chembl1200775 (LEUPROLIDE ACETATE) | — | Small molecule | 2041-12-22 | 15 patents | Composition of Matter Method of Use |
| Veklury (remdesivir) | Gilead Sciences | Small molecule | 2041-05-28 | 12 patents | Method of Use Other |
| Zyprexa (olanzapine) | Eli Lilly | Small molecule | 2041-11-12 | 12 patents | Formulation Method of Use |
| Austedo (DEUTETRABENAZINE) | Teva | Small molecule | 2041-06-10 | 8 patents | Method of Use |
| Bylvay (ODEVIXIBAT) | Ipsen | Small molecule | 2041-11-12 | 8 patents | Method of Use |
| Invega Sustenna (PALIPERIDONE PALMITATE) | Johnson & Johnson | Small molecule | 2041-05-07 | 8 patents | Method of Use |
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2041-01-06 | 7 patents | Other |
| Caduet (Amlodipine Besylate) | Pfizer Inc. | Small molecule | 2041-02-24 | 6 patents | Method of Use |
| Lioresal (BACLOFEN) | — | Small molecule | 2041-09-29 | 6 patents | Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2041-02-17 | 6 patents | Method of Use |
| Levophed (Norepinephrine Bitartrate) | Pfizer Inc. | Small molecule | 2041-03-08 | 5 patents | Formulation Method of Use |
| Radicava (EDARAVONE) | Kk Bcj-94 | Small molecule | 2041-11-12 | 5 patents | Method of Use |
| Ubrelvy (UBROGEPANT) | AbbVie | Small molecule | 2041-12-22 | 5 patents | Method of Use |
| lomitapide-mesylate (LOMITAPIDE MESYLATE) | — | Small molecule | 2041-07-29 | 5 patents | Method of Use |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2041-03-29 | 4 patents | Method of Use |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2041-05-23 | 4 patents | Method of Use |
| Clinimix E 2.75/5 Sulfite Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Container (POTASSIUM PHOSPHATE, DIBASIC) | Pfizer | Small molecule | 2041-10-12 | 4 patents | Method of Use |
| Crenessity (CRINECERFONT) | Neurocrine | Small molecule | 2041-06-09 | 4 patents | Method of Use |
| Daybue (TROFINETIDE) | Acadia Pharms Inc | Small molecule | 2041-02-03 | 4 patents | Other |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2041-04-01 | 4 patents | Method of Use Other |
| beclomethasone-dipropionate (BECLOMETHASONE DIPROPIONATE) | — | Small molecule | 2041-05-05 | 4 patents | Formulation |
| lazertinib-mesylate (LAZERTINIB MESYLATE) | — | Small molecule | 2041-04-13 | 4 patents | Formulation Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2041-12-15 | 3 patents | Formulation |
| Acthar Gel (CORTICOTROPIN) | Mallinckrodt Ireland | Small molecule | 2041-07-18 | 3 patents | Method of Use |
| Epidiolex (CANNABIDIOL) | Jazz Pharms Res | Small molecule | 2041-03-01 | 3 patents | Method of Use |
| Qulipta (ATOGEPANT) | AbbVie | Small molecule | 2041-07-29 | 3 patents | Method of Use |
| Xofluza (BALOXAVIR MARBOXIL) | Roche | Small molecule | 2041-04-21 | 3 patents | Formulation |
| Cozaar (LOSARTAN POTASSIUM) | Merck & Co. | Small molecule | 2041-10-07 | 2 patents | Formulation Method of Use |
| Daliresp (ROFLUMILAST) | Arcutis | Small molecule | 2041-12-03 | 2 patents | Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2041-01-14 | 2 patents | Method of Use |
| Evrysdi (RISDIPLAM) | Roche | Small molecule | 2041-04-15 | 2 patents | Composition of Matter |
| Krazati (ADAGRASIB) | Bristol-Myers Squibb | Small molecule | 2041-02-05 | 2 patents | Composition of Matter Method of Use |
| Leustatin (CLADRIBINE) | — | Small molecule | 2041-09-10 | 2 patents | Method of Use |
| Lynparza (olaparib) | AstraZeneca | Small molecule | 2041-10-25 | 2 patents | Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2041-07-31 | 2 patents | Formulation Method of Use |
| Paxlovid (Copackaged) (Nirmatrelvir) | Pfizer | Small molecule | 2041-08-05 | 2 patents | Method of Use |
| Posluma (FLOTUFOLASTAT F-18 GALLIUM) | Blue Earth | Small molecule | 2041-11-27 | 2 patents | Formulation Method of Use |
| cedazuridine (CEDAZURIDINE) | — | Small molecule | 2041-02-24 | 2 patents | Formulation Method of Use |
| naloxone-hydrochloride (Naloxone Hydrochloride) | Pfizer Inc. | Small molecule | 2041-02-05 | 2 patents | Method of Use |
| thiotepa (THIOTEPA) | — | Small molecule | 2041-08-16 | 2 patents | Formulation |
| terazosin-hydrochloride (TERAZOSIN HYDROCHLORIDE) | — | Small molecule | 2041-02-01 | 2 patents | Method of Use |
| Cubicin (Daptomycin) | Baxter | Small molecule | 2041-03-11 | 1 patents | Method of Use |
| Decadron (dexamethasone) | Generic (originally Merck) | Small molecule | 2041-04-26 | 1 patents | Method of Use |
| Eliquis (apixaban) | Bristol-Myers Squibb | Small molecule | 2041-05-22 | 1 patents | Other |
| Hernexeos (ZONGERTINIB) | Boehringer Ingelheim | Small molecule | 2041-07-21 | 1 patents | Method of Use |
| Litfulo (Ritlecitinib Tosylate) | Pfizer | Small molecule | 2041-10-17 | 1 patents | Composition of Matter |
| Solosec (SECNIDAZOLE) | Evofem Inc | Small molecule | 2041-12-11 | 1 patents | Method of Use |
| Wayrilz (RILZABRUTINIB) | Genzyme Corp | Small molecule | 2041-02-20 | 1 patents | Composition of Matter |
| Ycanth (CANTHARIDIN) | Verrica Pharms | Small molecule | 2041-02-19 | 1 patents | Formulation |
| hydroxyurea (HYDROXYUREA) | — | Small molecule | 2041-12-23 | 1 patents | Formulation |
| chembl-chembl112 (ACETAMINOPHEN) | — | Small molecule | 2041-07-09 | 1 patents | Formulation |
| succinylcholine-chloride (SUCCINYLCHOLINE CHLORIDE) | — | Small molecule | 2041-11-02 | 1 patents | Formulation |
| lutetium-lu-177-vipivotide-tetraxetan (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) | — | Small molecule | 2041-09-18 | 1 patents | Method of Use |
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.