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Biogen Will Assert New Tecfidera Patent Amid Hexal Germany Launch

Three Dimethyl Fumarate MAAs Were Approved By The EC In May

 
• By Dean Rudge

Biogen has conceded that generics to its Tecfidera treatment for relapsing remitting multiple sclerosis may launch “at risk” in the EU, after the US-based player was recently granted further patent protection until 2028.

Europe
Biogen is facing potential EU Tecfidera competition • Source: Shutterstock: Brazhyk

Biogen says it intends to enforce a newly issued European Tecfidera (dimethyl fumarate) dosing patent against “infringing generics,” but admits that it remains “possible generics may still launch at risk.”

The announcement comes weeks after Sandoz’s Hexal unit confirmed market entry in Germany for its generic version of the treatment for relapsing remitting multiple sclerosis, and with

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