[Edaily Reporter KIM SUNG-JIN ] SK Biopharm ( SK BIOPHARMACEUTICALS(326030)) announced on the 19th that it had reached an amicable settlement with Indian generic drugmaker MSN Laboratories (MSN) in a U.S. patent lawsuit related to “cenobamate” (U.S. brand name: Xcopri), an innovative new drug for epilepsy. The specific terms of the settlement are confidential.

SK BIOPHARMACEUTICALS agreed to grant MSN the right to launch generic products in the future. The agreement is subject to the scope of patent protection and related conditions, and pursuant to this settlement, the patent litigation between the two companies pending in the U.S. District Court for the District of Delaware has been resolved. This lawsuit concerned a dispute over a follow-on patent, separate from the substance patent for cenobamate. SK BIOPHARMACEUTICALS explained that this settlement has paved the way for it to maintain patent protection for the Excofry® product even after the substance patent expires in 2032. However, whether and when the generic product will actually be launched may vary depending on the approval process by U.S. regulatory authorities and the conditions stipulated in the confidential settlement agreement between the two companies.

SK BIOPHARMACEUTICALS assessed that this initial settlement will help solidify the foundation for the continued growth of Excofry® and contribute to maintaining its long-term market position in the U.S.

Excofry is a new epilepsy drug that SK BIOPHARMACEUTICALS developed entirely on its own—from candidate discovery through clinical trials to post-marketing—and currently serves as the company’s core cash cow. Excofry’s revenue for the second quarter of this year was 224.4 billion won, accounting for the majority of the company’s total revenue of 247.4 billion won. SK BIOPHARMACEUTICALS officially launched Excofry in the U.S. in May 2020. The company obtained a substance patent for cenobamate in October 2007 and received marketing approval for the new drug in November 2019.