Mumbai: Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Teriflunomide Tablets, 7 mg and 14 mg, a generic version of Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC.
With respect to 180-day generic drug exclusivity, it was one of the first ANDA applicants to submit a substantially complete ANDA for Teriflunomide Tablets, 7 mg and 14 mg, with a paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg.
Teriflunomide is formulated as film-coated tablets for oral administration. Teriflunomide is used to reduce flare-ups in people with relapsing multiple sclerosis (MS).
According to IQVIATM sales data for the 12 month period ending September 2018, the Aubagio Tablets, 7 mg and 14 mg market2 achieved annual sales of approximately $1.6 billion.
Glenmark’s current portfolio consists of 142 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the U.S. 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.