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Dupilumab patent expired?

See the DrugPatentWatch profile for Dupilumab

Dupilumab (Dupixent) patents have been partly expired / approaching expiry in some jurisdictions, but the situation is not uniform worldwide—there are usually multiple patents (compound, formulation, methods-of-use, second medical use, exclusivities, etc.), plus regulatory exclusivities (like orphan/biologic exclusivity) that can delay true generic/biosimilar launch.

What’s generally true

  • Original “compound” patents for dupilumab are widely understood to have expired or be nearing expiry, especially in major markets.
  • However, other patents and exclusivities can still protect certain indications, dosing regimens, or specific formulations.
  • Because dupilumab is a biologic, the “generic” equivalent is typically a biosimilar (or sometimes an interchangeably approved product).

    What this means for biosimilars

  • Some regions have already had biosimilar competition, and others may have delayed entry due to remaining patent coverage for particular claims/indications.
  • Whether a biosimilar is available (and when) depends on:
    1. the country
    2. which indication (asthma, AD, CRSwNP, etc.)
    3. which patents remain in force for that country/indication
    4. whether biosimilar approval has been granted and is marketed

      Quick question (so I can answer precisely)

      Which country/region are you asking about (US, EU, UK, Canada, India, etc.), and for which indication (e.g., atopic dermatitis, asthma, CRSwNP)?

      If you tell me the jurisdiction, I can summarize the likely status of relevant patent estates and remaining exclusivity barriers there.



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