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The US health regulator, US FDA, has approved Glenmark Pharmaceuticals Ltd’s Teriflunomide tablets, which used to treat multiple sclerosis into the US market. The approved product is a generic version of Sanofi-Aventis US’ Aubagio.
According to the company’s BSE filings, Glenmark Pharmaceuticals, USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg.
Glenmark stated, “with respect to 180-day generic drug exclusivity, it was one of the applicants to submit a substantially complete first abbreviated new drug application (ANDA) for Teriflunomide tablets.” Glenmark added, “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 the IQVIA sales data, the Aubagio tablets recorded an annual sales of around USD 1.6 billion for the 12-month period ending September 2018. With this approval the company’s current portfolio increased to 143 products authorised to be distributed in the US marketplace, However, 57 Abbreviated New Drug Applications (ANDAs) are still pending for approval with the USFDA.
