USFDA approves Lupin’s Dimethyl Fumarate Delayed-Release Capsules

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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 (US 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, 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 US (IQVIA MAT June 2020).