Mylan Triumphs In Tecfidera Patent Challenge
Biogen's Tecfidera Future Uncertain After Patent Challenge Loss To Mylan
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.
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Mylan is a step closer to realizing launch of a generic version of Biogen’s $3.3bn Tecfidera (dimethyl fumarate) multiple-sclerosis brand in the US after the originator was denied an injunction pending its appeal of an unfavorable patent decision at the district court level.
Biogen received a bump to biosimilar earnings in the first quarter of this year, but this reversed in Q2 with fewer new patients venturing out to begin treatment on its portfolio of chronic treatment options. Management addressed the numbers, as well as Mylan’s recent victory over its Tecfidera intellectual property in the US.
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.