TEVA

By Dean Seal

Catalyst Pharmaceuticals Inc. said it has received notice that Teva Pharmaceuticals Inc. is seeking regulatory approval to start producing a generic version of Firdapse, Catalyst's treatment for a rare muscle disease.

The Florida commercial-stage biopharmaceutical company said Monday that Teva has submitted an abbreviated new drug application to the U.S. Food and Drug Administration to manufacture, use, or sell a generic form of Firdapse.

In its notice to Catalyst, Teva said it plans to market its generic version before Catalyst's patents on Firdapse expire. Teva claims the patents aren't enforceable or valid, or at least won't be infringed upon by the commercial manufacture, use, or sale of the generic Firdapse Teva plans to make.

Catalyst has 45 days from its receipt of the notice letter to file a federal patent infringement lawsuit, which would prevent the FDA from considering Teva's application until when either May 1, 2026, or the entry of a judgment in Catalyst's favor first occurs.

Firdapse was approved in 2018 for the treatment of adults with Lambert-Eaton myasthenic syndrome.

Catalyst shares fell 13.5% to $18 in premarket trading Monday.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

January 23, 2023 09:20 ET (14:20 GMT)

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