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Biogen's Tecfidera Safe Following IPR Decision – For Now

Executive Summary

Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.

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Mylan Blocked By US Tecfidera Injunction

Mylan is aiming to be a first mover on generic Tecfidera (dimethyl fumarate), a brand with $3.3bn of sales last year, after successfully invalidating a key US patent shielding the multiple-sclerosis treatment until 2028. However, Biogen has procured a temporary injunction for now, as it seeks to defend its position on appeal.

Mylan Triumphs In Tecfidera Patent Challenge

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.

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.  

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