The epilepsy drugmaker posted record quarterly profit as it built patent and lifecycle teams to defend the medicine that generates 90% of revenue against generics and rival therapies.
SK Biopharmaceuticals has carved its intellectual property function out of its legal department and formed a standalone unit, while activating a Lifecycle Management (LCM, product extension strategy) team to defend Xcopri, the epilepsy medicine that contributes 90% of revenue, as its U.S. composition-of-matter patent expires in October 2032. The company is seeking to extend exclusivity through a method-of-use patent listed with the FDA (U.S. drug regulator) until June 2039, even as two ANDAs (U.S. generic drug applications) for cenobamate appeared on the FDA's Paragraph IV list last month, Drug Master File registrations rose to eight since 2023, and an Indian manufacturer prepared a local generic launch. The push comes after preliminary Q2 2025 results showed consolidated revenue of ₩247.4 billion, up 40.3% year over year, and operating profit of ₩97.1 billion, up 56.9%, with U.S. Xcopri revenue reaching ₩224.4 billion. Analysts said rival drug azetukalner from Xenon Pharmaceuticals is unlikely to dent Xcopri materially before 2028, while SK Biopharmaceuticals also pursues new formulations, broader seizure indications, pediatric expansion, approval in Japan, launches across Latin America, and reinvestment into CNS small molecules, radiopharmaceutical therapies, targeted protein degradation, and AI drug discovery with Insilico Medicine.