On Wednesday, Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) entered into a settlement agreement with Teva Pharmaceuticals Industries Ltd (NYSE:TEVA).

This Agreement resolves the patent litigation brought by Catalyst and its licensor SERB S.A in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Firdapse (amifampridine) 10 mg tablets before the expiration of the applicable patents.

If approved by the FDA, Teva will not market its generic version of Firdapse in the United States before February 25, 2035, unless certain limited circumstances customarily included in these types of agreements occur.

The parties will terminate all ongoing patent litigation between Catalyst/SERB and Teva regarding Firdapse patents pending in the U.S. District Court for the District of New Jersey.

The ongoing Firdapse patent litigation involves two defendants: Hetero, which is being challenged on all of Firdapse’s Orange Book-listed patents, and Lupin, which is facing a case focused on Catalyst’s Firdapse patent that expires in 2037.

In the Notice Letter in January 2023, Teva stated that it intended to market a generic version of Firdapse before the expiration of multiple of Catalyst’s patents listed in the FDA Orange Book.

In May, the FDA approved its supplemental New Drug Application, increasing the indicated maximum daily dose of Firdapse’s (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome (LEMS).

LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. Firdapse is a potassium channel blocker indicated for LEMS in adults and pediatric patients six years of age and older and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS.

In the third quarter of 2024, Firdapse revenues increased 19.7% year over year to $79.3 million. The company expects full-year 2024 net product revenue of $300 million—$310 million.

Price Action: CPRX stock closed at $19.53 on Wednesday.

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