Glenmark's generic Aubagio approved by FDA

Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296) has been granted final approval by the US Food and Drug Administration for teriflunomide tablets, 7mg and 14mg, a generic version of French pharma major Sanofi’s (Euronext: SAN) multiple sclerosis drug Aubagio.

With respect to 180-day generic drug exclusivity, the company notes that Glenmark was one of the first Abbreviated New Drug Applications (ANDA) to submit a substantially complete ANDA for teriflunomide tablets, 7mg and 14mg, with a Paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for teriflunomide tablets, 7mg and 14mg.

Market reaction to the news was positive, with Glenmark’s shares rising 1.5% in early trading this morning, but they fell back 2.23% to 650.00 rupees as the day progressed.

According to IQVIA sales data for the 12 month period ending September 2018, the Aubagio tablets, 7mg and 14mg market achieved annual sales of around $1.6 billion.

Glenmark’s current portfolio consists of 142 products authorized for distribution in the US marketplace and 57 ANDAs 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.