Catalyst Pharmaceuticals, Inc. has announced a settlement agreement with Teva Pharmaceuticals, resolving the patent litigation brought by Catalyst and its licensor, Serb S.A., in response to Teva's abbreviated new drug application seeking approval to market a generic version of Firdapse® (amifampridine) 10 mg tablets prior to the expiration of the applicable patents.
As part of the settlement, Teva receives a license to market the generic version of Firdapse beginning in February 2035, if approved by the U.S. Food and Drug Administration (FDA), unless certain limited circumstances occur. In accordance with the agreement, 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 pending Firdapse patent litigation against the remaining defendants, Hetero and Lupin, is ongoing.
Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) is a biopharmaceutical company committed to improving the lives of patients with rare diseases and has a proven track record of bringing life-changing treatments to the market. The company focuses on in-licensing, commercializing, and developing innovative therapies, prioritizing accessibility to ensure patients receive the care they need through a comprehensive suite of support services.
Catalyst Pharmaceuticals, headquartered in Coral Gables, Florida, was recognized as one of North America's fastest-growing companies on the 2024 Deloitte Technology Fast 500™ list. As a result of these announcements, the company's shares have moved 16.7% on the market, and are now trading at a price of $22.8. If you want to know more, read the company's complete 8-K report here.