Teva Seeking FDA OK to Make Generic Version of Firdapse for LEMS

But therapy maker Catalyst vows to enforce its property rights

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Teva Pharmaceuticals is seeking authorization from federal regulators in the U.S. to produce and sell a generic version of Firdapse (amifampridine), an approved treatment for Lambert-Eaton myasthenic syndrome (LEMS).

Firdapse, marketed by Catalyst Pharmaceuticals, was approved by the U.S. Food and Drug Administration in 2018 as the first and only oral therapy for the rare autoimmune disease. It’s covered by a string of patents, which are set to expire between 2032 and 2037.

Now Catalyst announced that it received a notice letter stating that Teva has submitted an abbreviated new drug application, or ANDA, to the FDA asking permission to manufacture and market a generic version of Firdapse.

“Catalyst is currently assessing the notice letter and intends to vigorously enforce its intellectual property rights relating to Firdapse,” the company stated in a press release.

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In the Paragraph IV Certification Notice Letter, Teva stated that it intends to market its generic product in the U.S. before Catalyst’s patents on the medicine expire.

According to the Catalyst statement, Teva alleged in its letter that the therapy maker’s patents “are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission.”

Under federal law, Catalyst has 45 days from the time it received the notice letter to initiate a patent infringement lawsuit against Teva in a federal district court, the company said. Such action could trigger a stay that prevents the FDA from approving Teva’s ANDA until mid-2026, or until a potential court ruling that Catalyst’s patents are invalid, unenforceable, or not infringed by Teva’s ANDA.

This is not the first time that Catalyst has been in conflict with other companies due to Firdapse’s intellectual property rights. Catalyst previously sued Jacobus Pharmaceutical over the approval of Ruzurgi, a therapy containing the same active ingredient as Firdapse that the FDA had approved to treat children with LEMS.

The FDA ultimately invalidated its approval of Ruzurgi, and the three-year legal battle ended last year in a settlement in which Catalyst acquired rights to Ruzurgi. The FDA also recently extended the approval of Firdapse to cover children as young as 6 years old.

LEMS is caused by an autoimmune attack that interferes with the communication between nerve and muscle cells. The active agent in Firdapse is designed to increase the amount of signaling molecules nerve cells release to cause muscle cells to contract, and ultimately reduce muscle weakness.