For the first time, SK Biopharmaceuticals has struck a settlement with a generics manufacturer that has applied for FDA approval of a copycat version of its epilepsy treatment, Xcopri (cenobamate), several Korean news outlets report.
SK’s deal is with India’s MSN Laboratories and will allow the Korean company to extend its market exclusivity beyond October 2032, when patent protection for its original compound is expected to expire. The settlement applies to follow-on patents that SK has erected to help extend its market exclusivity for Xcopri.
Terms of the settlement were confidential, per the reports.
“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 U.S.,” SK Biopharmaceuticals said, according to the Korea Herald.
SK did not immediately respond to Fierce's request for comment on the settlement. The deal was reported by multiple local Korean news outlets early Wednesday.
