PatentMay 7, 2026, 02:45 AM
Catalyst Pharma Settles FIRDAPSE Patent Suit; Generic Entry in 2035
AI Summary
Catalyst Pharmaceuticals announced a settlement agreement with Hetero Labs Ltd. and its affiliates, resolving patent litigation concerning Hetero's Abbreviated New Drug Application (ANDA) for a generic version of FIRDAPSE. Under the agreement, Hetero will not market its generic FIRDAPSE in the U.S. before January 2035. This settlement concludes all pending patent litigation related to FIRDAPSE, with all ongoing court cases to be terminated.
Key Highlights
- Catalyst Pharmaceuticals settled patent litigation with Hetero Labs Ltd. regarding generic FIRDAPSE.
- Hetero Labs Ltd. receives a license to market generic FIRDAPSE in the U.S. no earlier than January 2035.
- The agreement resolves all pending patent litigation related to FIRDAPSE.
- The parties will terminate ongoing litigation in the U.S. District Court for the District of New Jersey.
- Catalyst previously settled similar ANDA litigation for FIRDAPSE with Lupin, Teva, and Inventia.