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Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (NASDAQ:CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the Company and its licensor SERB S.A. ("SERB") have entered into a Settlement Agreement ("Agreement") with Lupin Ltd and Lupin Pharmaceuticals, Inc. (collectively, "Lupin"). This Agreement resolves the patent litigation brought by Catalyst and SERB in response to Lupin's Abbreviated New Drug Application ("ANDA") seeking approval to market a generic version of FIRDAPSE® (amifampridine) 10 mg tablets prior to expiration of the applicable patents.
Pursuant to the terms of the Agreement, Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, if approved by the U.S. Food and Drug Administration, 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 Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. Catalyst previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending FIRDAPSE patent litigation against the remaining defendant, Hetero, regarding FIRDAPSE's Orange Book-listed patents is ongoing.
As required by law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Posted In: CPRX
