Lupin gets approval for Dimethyl Fumarate Delayed-Release Capsules
6th Oct 2020

Lupin has received approval for its Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (USFDA), 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, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Dimethyl Fumarate Delayed-Release Capsules (RLD: Tecfidera) had an annual sales of approximately $ 3788 million in the U.S. (IQVIA MAT June 2020). 

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.