Supernus settles Trokendi XR patent litigation with Par

Supernus Pharmaceuticals' (Nasdaq: SUPN) shares leapt 10.85% to $15.45 on the news that it has entered into a settlement agreement with privately-held generics firm Par Pharmaceutical involving the ongoing patent litigation regarding Par's filing of an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Supernus' antiepileptic drug Trokendi XR (extended-release topiramate) capsules.

The settlement, often called a pay-for-delay deal, financial terms of which were not disclosed, permits Par to begin selling a generic version of Trokendi XR on April 1, 2025, or earlier under certain circumstances. The agreement is subject to entry of a consent judgment by the US District Court for the District of New Jersey. In the consent judgment, Par acknowledges that the Orange Book-listed patents for Trokendi XRowned by Supernus, namely US Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989, are valid and enforceable with respect to Par's ANDA product, and would be infringed by Par's ANDA product. The agreement will be submitted to the applicable governmental agencies.

The patent litigation continues against Actavis and Zydus, the other two ANDA filers. Patent protection for Trokendi XR expires no earlier than 2027 and Supernus intends to continue its vigorous enforcement of its patent rights. The drug generates more than 40% of Supernus’ annual sales.