Patent Cliff Calendar
Drugs losing US patent exclusivity in 2040
47 drugs face loss of exclusivity in 2040 · 47 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.
2040 is long-dated (14 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2040
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Cutivate (FLUTICASONE PROPIONATE) | Teva Pharm | Small molecule | 2040-02-20 | 28 patents | Formulation Other |
| solriamfetol-hydrochloride (SOLRIAMFETOL HYDROCHLORIDE) | — | Small molecule | 2040-03-19 | 24 patents | Method of Use |
| Risperdal (risperidone) | Johnson & Johnson (Janssen) | Small molecule | 2040-09-11 | 14 patents | Method of Use |
| Elucirem (GADOPICLENOL) | Guerbet | Small molecule | 2040-01-17 | 13 patents | Formulation Method of Use |
| Lumakras (SOTORASIB) | Amgen | Small molecule | 2040-05-20 | 12 patents | Method of Use |
| Ayvakit (AVAPRITINIB) | Blueprint Medicines | Small molecule | 2040-04-10 | 10 patents | Composition of Matter Method of Use |
| Benzamycin (BENZOYL PEROXIDE) | Mayne Pharma | Small molecule | 2040-02-19 | 10 patents | Method of Use |
| Nexletol (BEMPEDOIC ACID) | Esperion Theraps Inc | Small molecule | 2040-06-19 | 10 patents | Composition of Matter Formulation Method of Use |
| Scemblix (ASCIMINIB HYDROCHLORIDE) | Novartis | Small molecule | 2040-05-14 | 9 patents | Composition of Matter Formulation Method of Use |
| Vimpat (lacosamide) | UCB | Small molecule | 2040-06-05 | 9 patents | Method of Use |
| Farxiga (DAPAGLIFLOZIN) | AstraZeneca | Small molecule | 2040-01-18 | 6 patents | Method of Use Other |
| Pemazyre (PEMIGATINIB) | Incyte Corp | Small molecule | 2040-08-30 | 6 patents | Composition of Matter Method of Use |
| Romvimza (VIMSELTINIB) | Deciphera Pharms | Small molecule | 2040-02-03 | 6 patents | Method of Use |
| chembl-chembl2106195 (DEXMEDETOMIDINE HYDROCHLORIDE) | — | Small molecule | 2040-07-17 | 6 patents | Method of Use |
| Ozempic (semaglutide) | Novo Nordisk | Small molecule | 2040-05-13 | 5 patents | Method of Use |
| Topamax (topiramate) | Janssen | Small molecule | 2040-08-21 | 5 patents | Formulation Method of Use |
| Daybue (TROFINETIDE) | Acadia Pharms Inc | Small molecule | 2040-08-03 | 4 patents | Composition of Matter |
| Differin (ADAPALENE) | Galderma Labs Lp | Small molecule | 2040-07-31 | 4 patents | Formulation Method of Use |
| Erleada (apalutamide) | Johnson & Johnson | Small molecule | 2040-01-30 | 4 patents | Method of Use |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2040-05-28 | 4 patents | Composition of Matter Method of Use |
| Recorlev (LEVOKETOCONAZOLE) | Strongbridge | Small molecule | 2040-03-02 | 4 patents | Method of Use |
| Abilify (aripiprazole) | Generic (originally Otsuka/BMS) | Small molecule | 2040-11-03 | 3 patents | Formulation |
| Agamree (VAMOROLONE) | Catalyst Pharms | Small molecule | 2040-03-17 | 3 patents | Composition of Matter Method of Use |
| Bumex (BUMETANIDE) | — | Small molecule | 2040-12-04 | 3 patents | Formulation Method of Use |
| Onfi (CLOBAZAM) | Lundbeck Pharms Llc | Small molecule | 2040-01-31 | 3 patents | Method of Use |
| Zepzelca (LURBINECTEDIN) | Jazz Pharmaceuticals | Small molecule | 2040-05-29 | 3 patents | Method of Use |
| Brinsupri (BRENSOCATIB) | Insmed Inc | Small molecule | 2040-02-21 | 2 patents | Formulation |
| Ecclock (SOFPIRONIUM BROMIDE) | Kaken Pharmaceutical | Small molecule | 2040-05-22 | 2 patents | Composition of Matter |
| Lamictal (lamotrigine) | GSK | Small molecule | 2040-05-29 | 2 patents | Method of Use |
| Tymlos (ABALOPARATIDE) | Radius | Small molecule | 2040-01-10 | 2 patents | Method of Use |
| lazertinib-mesylate (LAZERTINIB MESYLATE) | — | Small molecule | 2040-05-21 | 2 patents | Method of Use |
| Aveed (TESTOSTERONE UNDECANOATE) | Marius | Small molecule | 2040-10-16 | 1 patents | Method of Use |
| Brukinsa (ZANUBRUTINIB) | BeiGene | Small molecule | 2040-06-10 | 1 patents | Formulation |
| Eliquis (apixaban) | Bristol-Myers Squibb | Small molecule | 2040-11-22 | 1 patents | Method of Use |
| Inomax (NITRIC OXIDE) | Vero Biotech Inc | Small molecule | 2040-07-22 | 1 patents | Method of Use |
| Jadelle (LEVONORGESTREL) | Fdn Consumer | Small molecule | 2040-09-07 | 1 patents | Formulation |
| Journavx (SUZETRIGINE) | Vertex Pharms Inc | Small molecule | 2040-12-04 | 1 patents | Method of Use |
| Kygevvi (DOXECITINE) | Ucb Inc | Small molecule | 2040-08-19 | 1 patents | Method of Use |
| Prilosec (omeprazole) | AstraZeneca (originally Astra AB) | Small molecule | 2040-03-01 | 1 patents | Method of Use |
| Rapamune (sirolimus) | Pfizer | Small molecule | 2040-10-28 | 1 patents | Formulation |
| Tegretol (carbamazepine) | Novartis AG (originally Geigy) | Small molecule | 2040-01-31 | 1 patents | Formulation |
| Wayrilz (RILZABRUTINIB) | Genzyme Corp | Small molecule | 2040-10-13 | 1 patents | Method of Use |
| vibegron (VIBEGRON) | — | Small molecule | 2040-03-22 | 1 patents | Method of Use |
| esketamine-hydrochloride (ESKETAMINE HYDROCHLORIDE) | — | Small molecule | 2040-02-18 | 1 patents | Method of Use |
| sodium-phenylbutyrate (SODIUM PHENYLBUTYRATE) | — | Small molecule | 2040-07-27 | 1 patents | Formulation |
| foscarbidopa (FOSCARBIDOPA) | AbbVie GK | Small molecule | 2040-06-10 | 1 patents | Method of Use |
| cedazuridine (CEDAZURIDINE) | — | Small molecule | 2040-10-07 | 1 patents | Formulation |
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.