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Mylan Blocked By US Tecfidera Injunction

Follows Key Patent Ruling In Company’s Favor In June

Executive Summary

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.

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Mylan Presses On With US Tecfidera Launch ‘At Risk’

Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.

Updated: Mylan Presses On With US Tecfidera Launch ‘At Risk’

Facing an appeal on a favorable US district court decision, Mylan has opted to launch “at risk” the first generic Tecfidera in the US, after obtaining FDA approval and seeing the originator’s bid for injunctive relief shot down earlier this month.

Mylan Overcomes Biogen Bid For Tecfidera Injunction

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.

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