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Xtandi patent expiration generic entry?

See the DrugPatentWatch profile for Xtandi

Short answer: In the United States, Xtandi (enzalutamide) is protected by multiple patents, with the key composition-of-matter patent expected to expire around 2027–2028, and additional related patents (including use and formulation patents) potentially extending protection into the early 2030s. Because of those patents and related litigation, generic entry has not occurred yet and is generally anticipated no earlier than the late 2020s, assuming patent challenges don’t derail it.

Notes:
- Data exclusivity does not block generics where patents are already challenged or invalidated, but it’s separate from patent protection.
- Patent expiration timelines vary by country (EU, other markets) and depend on the specific patent family, continuations, and any pediatric or other regulatory exclusivities.

If you’d like, I can pull the current US status (Orange Book listings and patent numbers) or provide country-specific timelines. Which market(s) are you interested in?



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