SK Biopharmaceuticals announced on the 19th that it had reached a settlement with Indian generic company MSN Laboratories in a patent lawsuit related to “XCOPRI,” the U.S. product of its epilepsy drug cenobamate. As a result, the litigation between the two companies pending before the U.S. District Court for the District of Delaware will be terminated.

The lawsuit concerned when generic products with the same active ingredient as XCOPRI could enter the U.S. market. SK Biopharmaceuticals has been engaged in patent litigation with three companies developing XCOPRI generics, and this is the first settlement it has reached, with MSN.

XCOPRI is an epilepsy treatment that SK Biopharmaceuticals developed independently, from discovery of the drug candidate through clinical trials to approval by the U.S. Food and Drug Administration (FDA). It received FDA approval in 2019 and was launched in the U.S. market in 2020.

The patent dispute began when generic manufacturers developed products with the same active ingredient as XCOPRI and applied for U.S. approval. SK Biopharmaceuticals filed patent infringement suits starting in 2024 against Aurobindo Pharma, Zydus Pharmaceuticals and others, and additionally initiated litigation when MSN applied for approval of a cenobamate generic in the same year.

The core issue in the dispute is the period after 2032, when cenobamate’s compound patent expires. The compound patent, which protects cenobamate as a new drug substance, is valid in the U.S. until 2032. Generic companies are not claiming they will sell products before that compound patent expires; rather, they are preparing to enter the market thereafter.

In addition to the compound patent, SK Biopharmaceuticals holds follow-on patents that protect methods of administering cenobamate to patients and dosage-adjustment regimens. Some of these follow-on patents extend until 2039.

Because of this, even after the compound patent expires in 2032, SK Biopharmaceuticals may have room to further protect XCOPRI’s market position through follow-on patents. Conversely, generic companies are seeking market entry by asserting that the relevant follow-on patents are invalid or that their products do not infringe them.

The settlement with MSN is the first outcome in this broader dispute. Based on the scope of SK Biopharmaceuticals’ patent protection and the terms agreed between the two companies, SK Biopharmaceuticals agreed to end the litigation while allowing MSN to launch a cenobamate generic in the future under certain conditions.

The specific timeframe when the generic may be launched has not been disclosed. Accordingly, this settlement does not mean MSN will enter the market immediately. Actual launch will require both completion of the U.S. regulatory approval process and satisfaction of undisclosed conditions agreed between the parties.

For SK Biopharmaceuticals, the first settlement among the three ongoing lawsuits with generic companies effectively removes one source of uncertainty. In particular, the fact that the follow-on patents were not held invalid by a court, and that the parties instead adjusted generic entry conditions while maintaining the existing patent framework, may positively affect XCOPRI’s long-term business stability.

If SK Biopharmaceuticals can use its follow-on patents to manage the timing of generic entry even after the compound patent expires, there is potential to maintain XCOPRI’s U.S. market position for a longer period. This is why the company views the settlement as an opportunity to secure a stable growth base for XCOPRI going forward.

There are, however, remaining variables. Patent litigation continues with other generic firms besides MSN, and it remains to be seen whether settlements will also be reached with them or how the courts will rule on the validity of the follow-on patents and whether they are infringed.

Should SK Biopharmaceuticals either reach similar settlements with the remaining companies or obtain judicial confirmation of the validity of its follow-on patents, it could be in a favorable position to maintain XCOPRI’s U.S. market status for a considerable period even after the compound patent expires in 2032.

SK Biopharmaceuticals expects that this initial settlement will help solidify the basis for XCOPRI’s continued growth and support the stable continuation of its long-term market position in the United States.

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