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.
SK filed its lawsuit against MSN in the U.S. District Court for Delaware in November of 2024, shortly after the generics specialist filed for its FDA nod. The lawsuit came four months after SK filed separate Xcopri patent infringement actions against Indian generics manufacturers Aurobindo and Zydus.
SK generates nearly all its revenue from Xcopri, which was approved by the FDA in 2019. Last year, the twice-daily oral treatment achieved sales of 707 billion Korean won ($480 million), which were up 29%. Earlier this month, in presenting its quarterly earnings, SK said that Xcopri sales were up 40% year over year.
After successful results from a phase 3 trial last year, SK hopes to expand Xcopri’s label to include patients with primary generalized tonic-clonic (PGTC) seizures. The original FDA nod for Xcopri covers it use in adults with partial-onset seizures.