Catalyst Pharmaceuticals announced a significant patent settlement with Teva Pharmaceuticals that extends market exclusivity for its rare disease drug Firdapse until 2035, resolving litigation over generic competition for the Lambert-Eaton myasthenic syndrome (LEMS) treatment.
The Florida-based biopharmaceutical company, along with its licensor SERB S.A., entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals that prevents the Israeli generic drugmaker from marketing its version of Firdapse 10 mg tablets before February 25, 2035, pending FDA approval.
Patent Litigation Resolution
The settlement resolves patent litigation initiated by Catalyst and SERB in response to Teva's Abbreviated New Drug Application seeking approval to market a generic version of Firdapse prior to patent expiration. The dispute involved multiple patents, including US Patent No. 10,626,088 for "Determining degradation of 3,4-diaminopyridine" and five additional patents (US Patent Nos. 10,793,893, 11,060,128, 11,268,128, 11,274,331, and 11,274,332) covering "methods of administering 3,4-diaminopyridine."
Under the agreement terms, all ongoing patent litigation between Catalyst/SERB and Teva regarding Firdapse patents pending in the U.S. District Court for the District of New Jersey will be terminated. However, patent litigation against remaining defendants Hetero and Lupin continues.
Regulatory Review Process
As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, a standard procedure for pharmaceutical settlement agreements.
Patrick McEnany, Catalyst's Co-Founder and Chairman, expressed satisfaction with the resolution, stating: "We are pleased to have reached a resolution with Teva and believe this agreement solidifies Firdapse's market exclusivity for many more years to come."
Previous Regulatory Challenges
Catalyst has previously faced significant challenges protecting Firdapse's market position. After FDA approval in 2018, the company was granted exclusivity through November 2025. However, that same year, rival Jacobus Pharmaceutical Company filed an NDA for Ruzurgi, another LEMS treatment.
The FDA circumvented Catalyst's exclusivity by separating Jacobus's NDA into pediatric and adult patient categories, arguing that Ruzurgi's approval for pediatric patients constituted a different "indication or use" from Firdapse's approval for adult patients, since Catalyst's drug is only approved for patients aged six and above.
Legal Precedent for Orphan Drug Exclusivity
Catalyst subsequently sued the FDA, alleging violation of the "same drug for the same disease or condition" restriction in the Orphan Drug Act, which grants seven years of regulatory exclusivity for designated rare disease treatments. While initially dismissed in the Southern District of Florida, the Court of Appeals for the Eleventh Circuit sided with Catalyst in September 2021, ruling that the FDA's action was "arbitrary, capricious and not in accordance with the law."
This appellate decision established a major precedent for orphan drug exclusivity in the United States, strengthening protections for rare disease treatments under the Orphan Drug Act.
