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

Biogen said it will appeal the district court decision invalidating the '514 patent for Tecfidera but Mylan said it looks forward to launching a generic after final FDA approval is granted. 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 Inc.'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.

A US District Court for the Northern District of West Virginia ruled in favor of patent challenger Mylan NV on 17 June, invalidating patent number 8,399,514, which protects Tecfidera...

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