Drugs losing US patent exclusivity in 2025
0 drugs face loss of exclusivity in 2025
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.
2025 is 1 year in the past — these drugs have already faced loss of exclusivity.
Drugs losing exclusivity in 2025
No drugs in our coverage face US loss of exclusivity in 2025 yet. As more patents are ingested across global jurisdictions, this list will fill in.
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.