Catalyst Pharmaceuticals announced a settlement with Lupin Pharmaceuticals regarding FIRDAPSE patent litigation.
Lupin receives a license to market generic FIRDAPSE starting in February 2035.
The settlement resolves ongoing patent litigation in response to Lupin's Abbreviated New Drug Application seeking approval for a generic version of FIRDAPSE.
Settlement Details
Lupin will not market generic FIRDAPSE in the U.S. before February 25, 2035, subject to FDA approval and certain conditions.
Litigation Resolution
The agreement includes termination of all ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents.
Legal Compliance
The companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
- The settlement secures Lupin's rights to market the generic version of FIRDAPSE without infringing Catalyst Pharmaceuticals' patents.
- Catalyst Pharmaceuticals can now focus on commercializing its innovative therapies without the burden of ongoing patent litigation.
The settlement marks a significant step in resolving patent disputes, allowing both companies to move forward in their respective pursuits. Catalyst Pharmaceuticals can now pursue its commitment to improving the lives of patients with rare diseases.