Catalyst Pharmaceuticals Settles FIRDAPSE Patent Litigation with Hetero Labs, Clearing All Pending ANDA Challenges

With the Hetero Labs settlement now executed, Catalyst Pharmaceuticals has closed the last open front in FIRDAPSE® (amifampridine) patent litigation, establishing a firm generic entry boundary of January 2035 and giving supply chain and regulatory teams a defined planning horizon for the rare neuromuscular disease treatment.

The agreement resolves litigation filed in response to Hetero's Abbreviated New Drug Application (ANDA) seeking pre-patent-expiry approval to market a generic version of FIRDAPSE 10 mg tablets in the United States. Under the settlement terms, Hetero Labs Ltd., Hetero USA, Grace Consulting Services, Inc., and Annora Pharma Private Limited are collectively barred from commercialising a generic version before the specified January 2035 date, contingent on FDA approval and absent the customary carve-out circumstances standard in Hatch-Waxman settlements. All pending proceedings in the U.S. District Court for the District of New Jersey will be terminated ahead of the trial date previously scheduled for May 18, 2026.

For regulatory affairs leads tracking the FIRDAPSE exclusivity landscape, the Hetero resolution completes a sequence that already included settlements with Lupin Pharmaceuticals, Teva Pharmaceuticals, and Inventia Healthcare Limited. No further ANDA-related patent challenges for FIRDAPSE remain outstanding, which simplifies the exclusivity defence posture Catalyst and licensor SERB S.A. must maintain through the remainder of the protection period.

As required under applicable federal law, the confidential settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, a standard procedural step for Hatch-Waxman patent settlements that carries no presumption of regulatory objection but does introduce a review window that compliance teams should note.

Manufacturing and supply planning for amifampridine, indicated for symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular condition, can now proceed against a stable competitive timeline, with the January 2035 generic entry date serving as the operative boundary for capacity, lifecycle, and post-approval change strategies.

Source: Catalyst Pharmaceuticals, Inc. via GlobeNewswire, May 7, 2026.