Catalyst Pharmaceuticals announced a settlement with Lupin Pharmaceuticals regarding FIRDAPSE patent litigation.
The agreement restricts Lupin from marketing the generic version of FIRDAPSE in the U.S. before February 25, 2035.
The settlement resolves ongoing patent litigation and includes provisions for FDA approval and termination of litigations.
Settlement Details
Lupin receives a license to market generic FIRDAPSE starting in February 2035 after the settlement.
Litigation Resolution
Agreement terminates ongoing patent disputes between Catalyst/SERB and Lupin regarding FIRDAPSE.
FDA Approval Conditions
Lupin can only market the generic FIRDAPSE after FDA approval and under specific circumstances as per the agreement.
- The settlement provides clarity for Catalyst Pharmaceuticals regarding the marketing and protection of FIRDAPSE.
- Restrictions on Lupin's marketing activities until 2035 secure Catalyst's market position for the drug.
The settlement with Lupin Pharmaceuticals marks a significant step for Catalyst Pharmaceuticals in protecting its FIRDAPSE patent and market exclusivity. The resolution of litigation enhances the company's position in the pharmaceutical market.