Glenmark Pharmaceuticals 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 Aubagio1 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.
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