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October 17, 2026 · Patent expires October 30, 2032

Xcopri (Cenobamate): The 2032-2039 Generic Opportunity Window

Xcopri (Cenobamate): The 2032-2039 Generic Opportunity Window

Xcopri (cenobamate, SK Biopharmaceuticals / SK Life Science, FDA NDA 212839) generated $429 million in 2025 U.S. net revenue (+44% YoY growth) as a premier antiepileptic therapy for partial-onset seizures. The loss of exclusivity (LOE) opportunity window spans from the 2032 core enantiopure carbamate substance patent (US 7,598,279, PTE through Oct 30, 2032) to the 2039 combination method-of-use patent (US 11,654,133, expiring Jun 16, 2039). Commercial status: 100% brand-only in the U.S. today, with confidential Hatch-Waxman litigation settlement executed with MSN Laboratories and active Paragraph IV ANDA filings from Aurobindo Pharma and Zydus Lifesciences.

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