1. Generics Bulletin

Teva Leapfrogs One ANDA Sponsor But Faces Decade Wait On US Firdapse Opportunity

Patent-Litigation Settlement Provides For February 2035 Entry; Two Actions Ongoing

 
• By Dean Rudge

Catalyst saw its share price jump by around 14% after striking what the market termed a favorable patent-litigation settlement agreement with ANDA sponsor Teva over its rare disease drug Firdapse.

a stylish mechanical watch on the arm of a man dressed in a blue jacket with a white shirt that watches the time on the clock holding the clock by hand

Teva looks set to wait until early in 2035 to launch its proposed generic version of Catalyst Pharmaceuticals’ Firdapse (amifampridine) 10mg tablets in the US, after striking a settlement agreement with the originator that resolves all litigation previously pending in a district court in New Jersey.

“Pursuant to the terms of the agreement, Teva will not market its generic version of Firdapse in the US any...

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