Teva’s planned generic version of Firdapse on hold in US until 2035
Company shelves attempt at FDA approval while Catalyst patents in effect
An agreement between Catalyst Pharmaceuticals and Teva Pharmaceuticals has ended a U.S. patent litigation case that began when Teva applied to produce and market a generic version of Firdapse (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS).
Under the terms of the settlement, announced by Catalyst, Teva will not market a generic formulation of Firdapse in the U.S. before Feb. 25, 2035. Catalyst’s licensor, SERB, was part of the agreement.
The likelihood of a generic Firdapse, which like other generics could be expected to come at a lower cost to patients, also is contingent upon U.S. Food and Drug Administration (FDA) approval of Teva’s marketing request.
Teva had argued that US patents for Firdapse did not apply to the generic
LEMS, an autoimmune disease, results from mistaken immune system attacks on a specific type of calcium channel found in nerve cell endings. These channels are needed for the release of acetylcholine, a chemical messenger that triggers muscle contraction, playing a key role in the control of voluntary muscle movement.
Common disease symptoms include muscle weakness, fatigue, and a lack of muscle reflexes. Muscle weakness can extend to affect a person’s vision, breathing, speech, chewing, and swallowing.
Firdapse is an oral medication that works to improve muscle strength and mobility in people with LEMS. Initially developed by BioMarin Pharmaceutical, Catalyst has held North American licensing rights since 2012. Firdapse was approved by the FDA in 2018 to treat LEMS in patients ages 17 and older. Its U.S. approval was expanded in 2022 to include children starting at 6 years old.
Catalyst holds several patents protecting Firdapse in the U.S., with expiration dates ranging between 2032 and 2037. Teva, arguing that these patents were not valid or enforceable, sought FDA authorization to manufacture and market a generic version of the therapy prior to those expiration dates.
In an application notice letter to Catalyst, Teva also stated that applicable patents would not be violated by the commercial production and marketing of the generic product. Catalyst, in turn, initiated a patent infringement lawsuit against Teva in a federal district court, leading to the recent settlement agreement.
Catalyst has been in patent litigation with other companies. One case, involving Jacobus Pharmaceutical, concerned the FDA’s 2019 approval of Ruzurgi to treat children with LEMS, ages 6 through 16. The therapy contains the same active ingredient as Firdapse, and the FDA invalidated Ruzurgi’s approval after a 2022 court ruling in Catalyst’s favor. The company soon afterwards acquired U.S. rights to this therapy.
Litigation is ongoing with Hetero and Lupin regarding Firdapse’s intellectual property rights, Catalyst stated in its release.
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