Catalyst Pharmaceuticals and Lupin have settled a legal dispute related to Lupin’s generic version of Firdapse (amifampridine) — an approved brand-name treatment for Lambert-Eaton myasthenic syndrome (LEMS).
Under the terms of the new deal, Lupin will not market its generic therapy in the U.S. prior to Feb. 25, 2035. That’s according to a press release from Catalyst, which holds the marketing rights to Firdapse in the U.S.
The dispute between the two companies arose when Lupin asked the U.S. Food and Drug Administration (FDA) to approve its generic version of Firdapse. The brand-name medication has been approved in the U.S. since 2018, and is now indicated for the treatment of LEMS patients ages 6 and older.
Catalyst sued its competitor, alleging that Lupin’s generic would infringe on its patent protections for Firdapse.
The FDA granted the generic tentative approval earlier this year, but the medication could not be brought to market until the patent litigation was resolved. Now, Catalyst and Lupin have struck an accord that terminates that litigation battle in U.S. District Court.
This isn’t the first time that Catalyst has gone to court to defend its intellectual property rights to Firdapse. The company previously struck similar deals with Teva Pharmaceuticals and Inventia Healthcare Limited — both of which were also looking to market generic versions of the therapy. A patent litigation over Firdapse’s intellectual rights with Hetero is ongoing.