Catalyst Pharmaceuticals settles FIRDAPSE patent case with Hetero Labs

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) announced it reached a settlement agreement with Hetero Labs Ltd. regarding patent litigation over the generic version of FIRDAPSE (amifampridine) 10 mg tablets.

Under the settlement terms, Hetero Labs will not market its generic version of FIRDAPSE in the United States before January 2035, pending FDA approval, unless certain limited circumstances occur. The agreement resolves patent litigation that was scheduled for trial on May 18, 2026, in the U.S. District Court for the District of New Jersey.

The litigation arose after Hetero Labs filed an Abbreviated New Drug Application seeking approval to market a generic version of FIRDAPSE before the applicable patents expired. Catalyst and its licensor SERB S.A. brought the patent case in response to this application.

This settlement concludes all pending patent litigation related to FIRDAPSE. Catalyst previously settled similar cases with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited regarding generic applications for the drug.

The companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, as required by law.

FIRDAPSE is approved for treating Lambert-Eaton myasthenic syndrome, a rare neuromuscular disorder. Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare and difficult-to-treat diseases, headquartered in Coral Gables, Florida.

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