Mylan launches generic Tecfidera in the US to treat Multiple Sclerosis.

Mylan N.V. announced the launch of the first 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 U.S. The generic launch comes after Mylan prevailed in a patent case against Biogen in West Virginia federal court. In a June decision, Judge Irene Keeley said Mylan “demonstrated by clear and convincing evidence” that certain claims of Biogen’s '514 patent are invalid for “lack of written description.” The patent was set to expire in 2028, so the decision will erode years of potential exclusivity if it's upheld on appeal..