SK Biopharm settles US patent suit over Xcopri, shoring up long-term market position

SK Biopharm announced Wednesday that it has reached a settlement with Indian generic pharmaceutical company MSN Laboratories in a US patent infringement lawsuit involving cenobamate, the company's proprietary epilepsy drug sold in the United States under the brand name Xcopri.

The lawsuit was triggered when MSN filed an application with the US Food and Drug Administration seeking approval to market a generic version of Xcopri. In response, SK Biopharm filed a patent infringement suit in 2024 in the US District Court for the District of Delaware to protect its patent rights.

MSN is the first of three defendants in SK Biopharm's ongoing US generic-related patent litigation to reach a settlement, bringing the case between the two companies in the Delaware federal court to a final close.

SK Biopharm agreed to grant MSN the right to launch a generic product in the future, subject to the scope of its patent protections and related conditions. The specific launch timing and detailed terms remain confidential under the agreement.

The dispute concerns follow-on patents separate from cenobamate's core compound patent. The compound patent for cenobamate is valid through October 2032, while the use patent runs through June 2039. SK Biopharm is pursuing a strategy to delay generic market entry by roughly seven years beyond the compound patent's expiration by leveraging the use patent.

Ahead of the US compound patent expiry, SK Biopharm established a dedicated in-house intellectual property team to strengthen its IP defense framework. The company plans to build a tighter follow-on patent defense network, starting with this first settlement, to solidify long-term patent protection in the United States. However, whether and when a generic product actually reaches the market may vary depending on US regulatory approval procedures and the terms of the confidential agreement.

SK Biopharm said the settlement — backed by its dedicated IP team — lays the groundwork for Xcopri to maintain its exclusive market position beyond the 2032 compound patent expiry while proactively reducing the risk of early generic entry. The company said it expects the agreement to help sustain Xcopri's growth and secure a stable long-term market position in the United States.