Catalyst Pharmaceuticals reports settlement of Firdapse patent litigation with Teva

Catalyst Pharmaceuticals (CPRX) announced that the company and its licensor SERB S.A. have entered into a Settlement Agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals (TEVA). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Teva’s Abbreviated New Drug Application seeking approval to market a generic version of FIRDAPSE 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Agreement, Teva will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if approved by the U.S. FDA, unless certain limited circumstances customarily included in these types of agreements 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. As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.