Mylan Launches Newly Approved Tecfidera Generic

August 19, 2020 – The U.S. FDA has approved Mylan’s generic version of Tecfidera® (dimethyl fumarate – Biogen) delayed release 120mg and 240mg capsules. Dimethyl fumarate is indicated to treat relapsing forms of multiple sclerosis (MS). This is the first generic available in the United States for an MS treatment in solid oral dosage form.

The recommended starting dose is 120mg twice a day for seven days, followed by a maintenance dose of 240mg twice a day. Dimethyl fumarate oral capsules should be taken whole, with or without food.

Mylan has launched the generic following the invalidation of a Tecfidera patent by the U.S. District Court for the Northern District of West Virginia. However, Biogen is appealing the court’s decision, and Mylan may be subject to damages if a court finds in Biogen’s favor and restores the patent. Tecfidera originally received FDA approval in 2013.

Mylan’s generic has a wholesale acquisition cost (WAC) of $7,142.43 per 60 tablets, compared to $8,275.89 for brand name Tecfidera.