Mylan announced the launch of FDA-approved therapeutically equivalent, substitutable generic of Biogen’s Tecfidera capsules. Dimethyl fumarate delayed-release capsules 120 mg and 240 mg are indicated for the treatment of relapsing forms of multiple sclerosis (MS), and are the first generic of any MS treatment in an oral solid dosage form available to patients in the US. 

The FDA approval follows Mylan’s win in the US District Court for the Northern District of West Virginia that invalidated Biogen’s Tecfidera patent, U.S. Patent No. 8,399,514. Biogen is appealing that decision. 

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