For the first time, SK Biopharmaceuticals has struck a settlement with a generics manufacturer who has applied for FDA approval of a copycat version of its epilepsy treatment Xcopri (cenobamate), several Korean news outlets report.\u00a0<\/p>\n
SK\u2019s deal is with India\u2019s MSN Laboratories and will allow the Korean company to extend its market exclusivity beyond October of 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.\u00a0<\/p>\n
Terms of the settlement were confidential, per the reports.\u00a0<\/p>\n
\u201cThrough this first settlement, we expect to strengthen the foundation for Xcopri\u2019s continued growth and contribute to maintaining its long-term market position in the U.S.,\u201d SK Biopharmaceuticals said, according<\/a> to the Korea Herald.<\/p>\n 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.\u00a0<\/p>\n SK filed its lawsuit against MSN in U.S. District Court in 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.<\/p>\n SK generates nearly all its revenue from Xcopri, which was approved<\/a> 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 it quarterly earnings, SK said that Xcopri sales were up 40% year over year.<\/p>\n