Glenmark Pharmaceuticals gets ANDA approval for multiple sclerosis drug

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for dimethyl fumarate delayed-release capsules, 120 mg and 240 mg, the generic version of Tecfidera1 delayed-release capsules, 120 mg and 240 mg, of Biogen.

Dimethyl fumarate is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

According to IQVIA sales data for the 12 month period ending August, the Tecfidera delayed-release capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.8 billion.

Glenmark’s current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA

In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.