SK Biopharmaceuticals has struck its first-ever settlement with a generic drug manufacturer seeking to produce a copycat version of its epilepsy treatment Xcopri (cenobamate).
The agreement is with India’s MSN Laboratories, which had applied to the US Food and Drug Administration for approval to market a generic version of the drug.
The settlement will allow SK to extend its market exclusivity for Xcopri beyond October 2032, when the original compound patent is expected to expire.
The deal specifically covers follow-on patents that SK has built up around Xcopri as part of a broader strategy to protect its long-term commercial position in the United States.
Terms of the agreement were kept confidential, according to multiple Korean news outlets that first reported the settlement early Wednesday.
“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 originally filed its lawsuit against MSN in the US District Court for Delaware in November 2024, shortly after the Indian generics firm submitted its FDA application.
That action followed separate Xcopri patent infringement cases filed by SK against Indian generic manufacturers Aurobindo and Zydus just four months earlier.
SK generates nearly all of its revenue from Xcopri, which received its initial FDA approval in 2019 as a twice-daily oral treatment for adults with partial-onset seizures.
Last year, Xcopri recorded sales of 707 billion Korean won, equivalent to approximately $480 million, representing growth of 29% year over year.
In its most recent quarterly earnings update, SK reported that Xcopri sales had accelerated further, climbing 40% compared with the same period the previous year.
Following successful results from a phase 3 clinical trial, SK is now pursuing an expanded FDA label to cover patients with primary generalized tonic-clonic seizures, broadening the drug’s potential patient population considerably.