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Vedolizumab patent expiry?

See the DrugPatentWatch profile for Vedolizumab

Vedolizumab’s original patent situation is a bit nuanced because there are multiple patent families and jurisdictions, and the “expiry date” people quote depends on whether you mean first approval exclusivity vs. last patent expiry.

What’s broadly true (high level)

  • Vedolizumab (Entyvio) was approved in the US in 2014 and in the EU in 2014.
  • As a biologic, it’s typically protected not just by one patent, but by several patents covering different aspects (process, formulation, specific claims, etc.).
  • First meaningful generic/biosimilar entry opportunities generally depend on a combination of:
    • Biosimilar regulatory pathways (e.g., EU/US biologics framework)
    • US/EP patent expirations and litigation outcomes
    • Exclusivity periods

The practical “answer” people usually care about

By now, biosimilars of vedolizumab are already entering / available in some markets, which usually indicates that the key exclusivity/patent barriers are no longer fully blocking launch in those regions.

However, I don’t want to guess a single “exact expiry date” without knowing the country/region you mean.

Quick questions so I can give the correct date

  1. Which country/region? (US, EU/UK, Canada, etc.)
  2. Are you asking for last patent expiry or regulatory exclusivity expiry (or both)?
  3. If you know it: which company brand name (Entyvio) and/or patent list you’re looking at?

If you tell me the jurisdiction (e.g., US vs EU), I can give you the most relevant expiry/launch-impact dates.



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