SK Biopharmaceuticals has reached a settlement with Indian generic drug developer MSN Laboratories in a U.S. patent lawsuit regarding the epilepsy drug Xcopri. The agreement allows MSN to market a generic version between 2032 and 2039, ending litigation in Delaware federal court while leaving two separate lawsuits active.
The dispute centers on the epilepsy drug cenobamates, known in the United States by its product name Xcopri.
Patent Timeline and the MSN Laboratories Settlement
The litigation before the U.S. District Court for the District of Delaware involved follow-on patents rather than the primary substance patent. According to company representatives, the material patent for cenobamate expires in 2032, while the related use patents run until 2039.
The material patent expiration timing for cenobamate is 2032 and the use patent expiration timing is 2039. An agreement was reached for an Indian company to launch a generic drug between 2032 and 2039, but specific conditions cannot be disclosed. SK Biopharmaceuticals official, via Yonhap News
While the financial and operational terms of the settlement remain confidential, the resolution terminates the active patent lawsuit between the two companies in Delaware.
Remaining Litigation and Regulatory Hurdles
The legal resolution applies exclusively to MSN Laboratories. Two additional generic drug developers remain locked in active patent litigation with SK Biopharmaceuticals over the same product portfolio.
Even with the negotiated window between 2032 and 2039, actual market entry depends on regulatory oversight. Regulatory authorities in the United States must still review and approve any generic product applications before commercial distribution can begin, meaning the exact launch timeline remains variable.
Strategic Impact on U.S. Market Position
Company officials maintain that securing this initial agreement establishes a foundation for ongoing portfolio expansion and protects the brand’s commercial footprint well beyond the expiration of the primary substance patent.
Through this first agreement, we have laid the foundation for continued growth and will be able to maintain our market position. SK Biopharmaceuticals official, via Yonhap News
Outside of its direct U.S. commercial operations, SK Biopharmaceuticals continues to distribute Xcopri internationally through commercial partners across Europe, Latin America, the Middle East, North Africa, and Asia.
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