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SK Bioscience settles patent dispute with Indian firm over epilepsy drug XCOPRI
🇰🇷 South Korea /Economy & Trade

SK Bioscience settles patent dispute with Indian firm over epilepsy drug XCOPRI

From Dong-A Ilbo · () Korean

Translated from Korean, summarized and contextualized by DistantNews.

At a glance

News Official statement Outcome reported
  • SK Bioscience has settled a patent lawsuit with Indian generic drug maker MSN Laboratories regarding its epilepsy drug XCOPRI.
  • The settlement ends a dispute over when generic versions of XCOPRI, which contains cenobamate, can enter the U.S. market.
  • This agreement is the first settlement in SK Bioscience's patent disputes with three generic companies, reducing uncertainty for the long-term market position of XCOPRI.

SK Bioscience has reached a settlement with Indian generic drug maker MSN Laboratories in a patent dispute concerning its epilepsy drug XCOPRI. The agreement resolves a lawsuit filed in the U.S. District Court of Delaware, which centered on the market entry timeline for generic versions of XCOPRI, a U.S. product containing cenobamate.

This marks the first settlement SK Bioscience has achieved with three companies developing generic versions of XCOPRI. The company had initiated patent infringement lawsuits against companies like Aurobindo Pharma and Zenera Pharma in 2024, and subsequently sued MSN when it applied for approval of a cenobamate generic.

SK Bioscience has settled a patent lawsuit with Indian generic drug maker MSN Laboratories regarding its epilepsy drug XCOPRI.

— SK BioscienceOfficial statement announcing the settlement.

The core of the dispute revolves around the substance patent for cenobamate, which is valid until 2032 in the U.S. Generic companies are preparing for market entry after this date. However, SK Bioscience also holds secondary patents covering methods of administration and dosage adjustments, some of which extend to 2039. These patents could allow SK Bioscience to maintain XCOPRI's market position even after the substance patent expires.

Through the settlement with MSN, SK Bioscience will allow the company to launch its cenobamate generic under specific conditions related to patent protection and agreed-upon terms, in exchange for ending the lawsuit. The exact launch date for MSN's generic product was not disclosed, and actual market entry is contingent on regulatory approval and meeting the private terms of the agreement. This settlement reduces uncertainty for SK Bioscience, potentially bolstering XCOPRI's long-term business stability by maintaining its existing patent framework while negotiating generic entry terms.

This settlement is the first reached in patent disputes with three generic companies, reducing future uncertainties for XCOPRI's market position.

— SK BioscienceAnalysis of the settlement's impact on the company's business.
DistantNews Editorial

Originally published by Dong-A Ilbo in Korean. Translated, summarized, and contextualized by our editorial team with added local perspective. Read our editorial standards.

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