Mylan launches first generic of Tecfidera in the US Posted 11/09/2020

On 19 August 2020, Mylan announced the launch of the first US Food and Drug Administration (FDA) approved generic of Biogen's multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate).

Mylan’s dimethyl fumarate delayed release capsules, available in 120 mg and 240 mg doses, are indicated for the treatment of relapsing forms of MS. They are the first generic of any MS treatment in an oral solid dosage form to be made available to patients in the US. 

Mylan CEO Heather Bresch said: ‘The launch of the first generic Tecfidera is yet another prime example of Mylan's fundamental commitment to bringing more access to patients worldwide, in this particular case through our important continued support of the MS community, while helping to provide immediate and substantial savings for the U.S. healthcare system’.

FDA approval, which was granted on 17 August 2020, follows a ruling by the US District Court for the Northern District of West Virginia invalidating Biogen’s patent on Tecfidera. Biogen has pledged to appeal this decision, which puts Mylan at risk of paying damages of up to triple the amount of the branded drugmaker's lost revenue should Biogen win the appeal. Conversely, should Biogen lose the appeal, other generics may soon follow because the invalidated Tecfidera patent – which was due to expire in 2028 – was the lone remaining patent on the drug.

Biogen's total sales in the US for the 12 months ending 30 June 2020, were approximately US$3.79 billion for Tecfidera, according to IQVIA data.

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