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Glenmark receives final approval from USFDA for generic version of Benicar Tablets

26 May 2017 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg, the generic version of Benicar Tablets, 5 mg, 20 mg and 40 mg, of Daiichi Sankyo, Inc. Glenmark’s Olmesartan Medoxomil Tablets will be manufactured by Glenmark Pharmaceuticals in its manufacturing facility located in Goa, India.

According to IMS Health sales data for the 12 month period ending March 2017, the Benicar Tablets, 5 mg, 20 mg and 40 mg market achieved annual sales of approximately $950.0 million.

Glenmark’s current portfolio consists of 115 products authorized for distribution in the US marketplace and approximately 69 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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