Glenmark receives ANDA approval for Rufinamide Tablets

19 May 2016 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for its Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg of Eisai, Inc. According to IMS Health sales data for the 12 month period ending March 2016, the Banzel market achieved annual sales of approximately $155.1 million.

With respect to 180-day generic drug exclusivity, Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification. Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Rufinamide Tablets USP, 200 mg and 400 mg.

Glenmark’s current portfolio consists of 113 products authorized for distribution in the U.S. marketplace and 63 ANDA’s pending approval with the USFDA. 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.



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