Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) 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, the company 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, the company is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg. According to IQVIA sales data for the 12 month period ending September 2018, the Aubagio Tablets, 7 mg and 14 mg market achieved annual sales of approximately $1.6 billion.
The company’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, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).