Dupixent patent expiration date?

Dupixent (dupilumab) – key patent expiration dates

Bottom line:
The principal U.S. patents that cover the drug substance, its formulation, and the major therapeutic indications for Dupixent all expire on March 29, 2027.

Why this matters

1. Patent protection ends – Once a patent expires, competitors can potentially manufacture and market generic versions of dupilumab, provided they also obtain regulatory approval (FDA approval, not just patent freedom).
2. Post‑expiration “patent life” – Even after the patents expire, the manufacturer (Sanofi / Regeneron) may retain commercial exclusivity through:
   • Regulatory exclusivity (e.g., FDA’s 12‑year New Chemical Entity exclusivity, 8‑year Orphan Drug exclusivity for certain indications).
   • Data exclusivity (additional 5‑year periods that prevent generic applicants from using the original clinical trial data).

Because of these additional protections, a generic version of Dupixent might not become available until 2029–2030 or later, even though the patents themselves expire in 2027.

How to keep up

If you’re looking for the exact expiration for a specific country’s patent (outside the U.S.), let me know the country, and I can pull the relevant dates for you.