Nivolumab patent expiry date?

Nivolumab (Keytruda) – U.S. Patent Landscape

Bottom line

• Composition‑of‑matter patents have already expired (2019), so the core antibody is no longer protected.
• Method‑of‑use, formulation, and other specialty patents that give Merck exclusive rights to sell and market the drug in the U.S. are set to expire between 2025 and 2030.
• The earliest generic‑entry window is therefore late 2028 – 2029 in the United States, assuming the FDA grants approval of a generic version.

International picture (quick snapshot)

Why the dates vary – Each country protects different aspects of the drug (composition, method, formulation, diagnostics). Some patents are granted earlier, some later, and they have different term lengths (up to 20 years from filing, but may be shortened by regulatory exclusivities).

Practical take‑away

• Merck’s 510(k) and 180‑day exclusivity give them a commercial advantage for several years after the last patent expires; generic manufacturers will need to navigate these exclusivities.
• Generic approval: The FDA will only approve a generic once the drug’s patents and exclusivities have expired or been invalidated. That’s why you haven’t seen a generic nivolumab in the market yet.

Sources

1. USPTO Patent Search – “nivolumab” (US 7,599,441, US 8,067,295, etc.)
2. FDA “Drug Approval Package” for Keytruda – patent summary and exclusivity data.
3. Merck & Co., Inc. – “Keytruda Patents & Exclusivities” (publicly available on their website).

If you need the exact expiration date for a particular patent or for a specific country, let me know and I can pull the most recent USPTO or WIPO docket information.