Pharma major Lupin Limited (Lupin) announced that it has received approval for its Dimethyl Fumarate Delayed-Release Capsules, 120 mg, and 240 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Tecfidera Delayed-Release Capsules, 120 mg, and 240 mg, of Biogen, Inc. The product is expected to be launched shortly.

Dimethyl Fumarate Delayed-Release Capsules, 120 mg, and 240 mg are indicated for the treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Dimethyl Fumarate Delayed-Release Capsules (RLD: Tecfidera) had annual sales of approximately USD 3788 million in the U.S.