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See the DrugPatentWatch profile for xcopri
As of now, there is no generic Xcopri (cenobamate) available. What affects when a generic could appear: - In the U.S., generics can only enter after the 5-year data exclusivity for a new chemical entity expires and after any associated patents expire. Cenobamate was approved in 2019, so the basic data exclusivity would typically run through around 2024, but patent protections could extend that timeline. - There are likely one or more patents covering cenobamate that may protect it well beyond 2024, possibly into the 2030s, depending on litigation, settlements, and expiration dates. Because the exact date depends on patent terms and any legal outcomes, there isn’t a fixed forecast. The best way to get an up-to-date answer is to check: - FDA Orange Book entries for cenobamate (Xcopri) to see listed patents and expiration dates and any exclusivities. - Any statements from SK Life Science or generic manufacturers. If you’d like, I can guide you to the specific Orange Book page and help interpret the patent/exclusivity details.
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