Teva Seeks FDA OK for Generic Form of Catalyst's Firdapse
23 Januar 2023 - 3:35PM
Dow Jones News
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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