Deal reached in US legal dispute over approved Firdapse generic
Lupin's treatment for LEMS now won't reach US market until 2035
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.
Catalyst has struck similar deals over rights to Firdapse
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.
Catalyst was also involved in a years-long court battle with Jacobus Pharmaceutical over allegations that a therapy sold by Jacobus infringed on Catalyst’s patent protections for Firdapse. Catalyst ultimately won rights to Jacobus’ therapy, Ruzurgi, as part of a settlement reached in 2022.
An autoimmune disease, LEMS is caused by antibodies that mistakenly attack voltage-gated calcium channels (VGCCs), which are proteins required for communication between nerve and muscle cells. The immune attack on VGCCs means that nerves are not able to efficiently send signals to instruct muscle cells to contract, ultimately leading to symptoms of muscle weakness and fatigue.
Amifampridine, Firdapse’s active ingredient, boosts the activity of VGCCs, strengthening signals from nerve cells and ultimately helping to ease LEMS symptoms. Generic versions of the therapy would have an identical active ingredient.
The only possible exception to the newly struck deal would be due to “certain limited circumstances customarily included in these types of agreements,” per the release. Catalyst did not provide further details on the deal, but noted that the full settlement will be submitted to the appropriate legal authorities as required by law.
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