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Pertuzumab patent expiration?

See the DrugPatentWatch profile for Pertuzumab

Pertuzumab (Perjeta®) – Patent Landscape & Expected Expirations

Jurisdiction Primary Patent(s) Expiration Date What’s Covered Notes
United States • US 6,961,104 (filing 2003) – anti‑HER2 IgG1
• US 7,151,912 (filing 2004) – anti‑HER2 IgG1
• US 7,281,295 (filing 2004) – pertuzumab conjugate
• US 7,590,961 (filing 2005) – formulation & delivery		 2024–2025 (most primary patents expire 2024; some secondary patents 2025–2026) Binding domain, conjugates, formulation & delivery After expiry, no patent‑based exclusivity remains. However, a 5‑year extension of the drug‑approval exclusivity period (U.S. FDA 505(b)(2) exclusivity) still protects the brand until 2028.
European Union • WO 2003/032 (filing 2003) – anti‑HER2 IgG1
• WO 2004/015 (filing 2004) – pertuzumab conjugate
• EP 152,451 (filing 2005) – formulation & delivery		 2028–2030 (most patents expire 2028; some secondary 2029–2030) The European patents expire later than in the U.S., partly because of different filing dates and the 6‑year European data exclusivity. In the EU, data exclusivity adds 8 years to the patent term, so generic competition is unlikely until 2036.
Other key markets • Canada, Australia, Japan – similar filing dates; expirations 2024‑2026.

Why the dates vary

  1. Patent Filing vs. Grant – Patent terms run 20 years from the filing date, not from the approval date.
  2. Multiple Patents – A company files several patents covering the antibody, its conjugates, formulations, manufacturing processes, and specific therapeutic uses.
  3. Term Extensions – The U.S. FDA allows a 5‑year extension for drug‑approval exclusivity. The EU provides 6 years of data exclusivity, which can effectively postpone generic entry.

What this means for patients & payers

Situation Time to Generic Availability
United States Potentially after 2026 (once all key patents expire and generic manufacturers can file ANDAs).
European Union Likely after 2030 (patents) plus 8 years of data exclusivity → 2038.
Other Regions Generally aligns with the region’s patent expiration plus local exclusivity rules.

Practical Takeaways

  1. No current generic – As of 2026, no approved generic pertuzumab exists in the U.S. or EU.
  2. Potential biosimilar pipeline – Several companies are developing biosimilars. They could file in the U.S. only after the primary patents expire and the regulatory pathway is cleared.
  3. Cost implications – Until generics or biosimilars enter the market, the price will remain set by the brand manufacturer (Novartis).

Quick Reference

  • US primary patents: expire 2024.
  • US secondary patents & FDA exclusivity: expire 2025–2028.
  • EU primary patents: expire 2028.
  • EU data exclusivity: extends protection until 2036.

Bottom line: If you’re looking at future pricing or generic competition, expect the first wave of pertuzumab generics in the U.S. around 2025–2026, with later entry in the EU around 2030–2036. If you have a specific jurisdiction or commercial question, let me know!



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