Glenmark Pharmaceuticals Inc., USA (Glenmark) 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®1 Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC.
With respect to 180-day generic drug exclusivity, we note that Glenmark 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.
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.
1All brand names and trademarks are the property of their respective owners.
2Market includes brand and all available therapeutic equivalents
*IQVIATM National Sales Perspectives: Retail & Non-Retail, September 2018