1. Generics Bulletin

Mylan Triumphs In Tecfidera Patent Challenge

Biogen's Tecfidera Future Uncertain After Patent Challenge Loss To Mylan

 
• By Jessica Merrill

Following a district court decision invalidating the '514 patent for Tecfidera, Mylan says it looks forward to launching a generic after final FDA approval is granted, despite Biogen saying it will appeal the ruling. The ANDA has a November action date.

Patent Law Concept 3D Illustration
Mylan wins a patent challenge over Biogen's Tecfidera • Source: Shutterstock

A district court decision invalidating a critical patent for Biogen's multiple sclerosis blockbuster Tecfidera (dimethyl fumarate) could pave the way for generic versions of the drug earlier than expected, although the timing remains uncertain.

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