Drugs losing US patent exclusivity in 2045
7 drugs face loss of exclusivity in 2045 · 7 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.
2045 is long-dated (19 years away). Revenue is shielded from biosimilar / generic competition through the medium term.
Drugs losing exclusivity in 2045
| Drug | Manufacturer | Type | Earliest expiry | Patent estate | Patent classifications |
|---|---|---|---|---|---|
| Paraplatin (Carboplatin) | MYLAN SEIYAKU Ltd | Small molecule | 2045-04-01 | 3 patents | Formulation |
| Romvimza (VIMSELTINIB) | Deciphera Pharms | Small molecule | 2045-04-30 | 3 patents | Formulation |
| resmetirom (RESMETIROM) | — | Small molecule | 2045-02-04 | 3 patents | Method of Use |
| Bumex (BUMETANIDE) | — | Small molecule | 2045-05-14 | 1 patents | Method of Use |
| Epipen (epinephrine) | Pfizer Inc. | Small molecule | 2045-01-17 | 1 patents | Formulation |
| Mobic (MELOXICAM) | Boehringer Ingelheim | Small molecule | 2045-03-10 | 1 patents | Method of Use |
| elinzanetant (ELINZANETANT) | — | Small molecule | 2045-05-14 | 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.