On Wednesday, Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) announced a settlement agreement with Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) to resolve patent litigation related to Firdapse (amifampridine) 10 mg tablets. This agreement stemmed from a legal dispute initiated by Catalyst and SERB S.A, the licensor, in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Firdapse before the relevant patents’ expiration.
Per the terms of the settlement, if approved by the FDA, Teva will refrain from launching its generic version of Firdapse in the U.S. until February 25, 2035, barring certain exceptional circumstances typical of such agreements. Furthermore, all ongoing patent litigation concerning Firdapse patents between Catalyst/SERB and Teva in the U.S. District Court for the District of New Jersey will be terminated.
The patent dispute related to Firdapse involves two defendants: Hetero, challenging all Orange Book-listed patents, and Lupin, facing a case centered on Catalyst’s Firdapse patent expiring in 2037. In a Notice Letter dated January 2023, Teva expressed its intent to introduce a generic Firdapse version before the expiration of multiple patents listed in the FDA Orange Book.
In May, the FDA granted approval for a supplemental New Drug Application increasing the maximum daily dose of Firdapse for adults and pediatric patients weighing over 45 kg from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness and fatigue. Firdapse, a potassium channel blocker, is indicated for LEMS in adults and pediatric patients aged six and above. Its mechanism involves enhancing acetylcholine release at the neuromuscular junction, thereby aiding muscle function in LEMS patients.
During the third quarter of 2024, Firdapse revenues surged by 19.7% year-over-year to $79.3 million. The company anticipates net product revenue of $300 million to $310 million for full-year 2024.
CPRX stock closed at $19.53 on Wednesday.
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