Catalyst Pharmaceuticals Settles FIRDAPSE® Patent Litigation; Hetero Labs to Market Generic in 2032

Catalyst Pharmaceuticals and Hetero Labs Ltd. have reached a settlement in their patent litigation concerning FIRDAPSE® (amifampridine). The agreement resolves all outstanding patent disputes between the two companies related to Catalyst’s drug, which is used to treat Lambert-Eaton myasthenic syndrome (LEMS).

As part of the settlement, Hetero Labs is permitted to market a generic version of amifampridine in the United States beginning January 1, 2032, or earlier under certain circumstances. Additional details of the agreement remain confidential. The settlement brings an end to the legal challenges Catalyst Pharmaceuticals faced in protecting its intellectual property rights for FIRDAPSE®.

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Date: May 7, 2026

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GOAI