SK Biopharm Settles US Patent Suit Over Xcopri, Reinforcing Long-Term Market Exclusivity
核心洞察
SK Biopharm (搜索) reached a settlement with Indian generic maker MSN Laboratories (搜索) in a US patent infringement suit over cenobamate, the active ingredient in epilepsy (搜索) drug Xcopri.
The settlement grants MSN future rights to launch a generic, subject to patent protections, with specific timing and terms kept confidential.
Xcopri's compound patent runs through October 2032, while a use patent extends to June 2039, supporting a strategy to delay generic entry by roughly seven years.
SK Biopharm (搜索) announced Wednesday that it has reached a settlement with Indian generic pharmaceutical company MSN Laboratories (搜索) in a US patent infringement lawsuit involving cenobamate, the company's proprietary epilepsy (搜索) drug sold in the United States under the brand name Xcopri. The settlement brings the case between the two companies in the US District Court for the District of Delaware to a final close, with MSN becoming the first of three defendants in SK Biopharm's ongoing US generic-related patent litigation to reach a settlement.
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 (搜索) filed a patent infringement suit in 2024 in the US District Court for the District of Delaware to protect its patent rights.
Under the agreement, SK Biopharm (搜索) 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.
Patent Structure and Defense Strategy
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 (搜索) 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 (搜索) 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.
Commercial Significance
SK Biopharm (搜索) 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.
Xcopri accounts for 90% of SK Biopharm (搜索)'s total revenue, underscoring the commercial importance of defending its market exclusivity. The company has also activated a Lifecycle Management (LCM) team responsible for expanding product formulations and indications, focusing on maximizing Xcopri's long-term value. An SK Biopharmaceuticals representative stated, "With the IP and LCM teams at the core, we are actively responding to patent challenges and expanding indications and target patient populations. We are concentrating on maximizing cenobamate's long-term value, including extending the period of market exclusivity."
The generic threat is already materializing. According to the FDA's "Paragraph IV" list, two Abbreviated New Drug Applications (ANDAs) for generic versions of cenobamate have been registered, and Drug Master File (DMF) registrations have increased to eight since 2023. The settlement with MSN represents the first resolution among these challenges, with two additional defendants still in litigation.