KB News Desk
SK Biopharmaceuticals said Wednesday it has reached a settlement with Indian generic drugmaker MSN Laboratories in a United States patent dispute over cenobamate, its epilepsy treatment sold as Xcopri in the US, laying the groundwork for continued patent protection for the drug in the world’s largest pharmaceutical market.
Although the terms of the agreement were not disclosed, it marks the first resolution in SK Biopharmaceuticals’ strategy to defend Xcopri’s intellectual property rights against generic competition in the US.
In June 2024, the Korean drugmaker filed patent infringement lawsuits against Indian drugmakers Aurobindo Pharma and Zydus Pharmaceuticals. It filed a separate lawsuit against MSN in November of the same year after the Indian company sought US Food and Drug Administration approval for a generic version of Xcopri.
SK Biopharmaceuticals argued that MSN’s proposed generic drug infringed patents related to Xcopri, prompting the legal dispute in US federal court.
According to SK Biopharmaceuticals, the settlement concerns follow-on patents separate from cenobamate’s composition-of-matter patent. The US composition-of-matter patent for cenobamate remains in effect through October 2032. The company said the follow-on patents provide a basis for maintaining patent protection for Xcopri after the core patent’s expiration.
Under the settlement, however, SK Biopharmaceuticals agreed to grant MSN the right to launch a generic version of Xcopri in the future. The actual launch and timing of MSN’s generic product could vary depending on the US regulatory approval process and the conditions in the companies’ confidential agreement.
As Xcopri sales continue to grow in the US, the agreement with MSN is expected to help manage some of the uncertainties surrounding potential generic entry and provide greater stability for the drug’s commercialization period.
“Through this first settlement, we expect to strengthen the foundation for Xcopri’s continued growth and contribute to maintaining its long-term market position in the US,” SK Biopharmaceuticals said.
