 "Glenmark receives US FDA approval for hypertension drug nebivolol")
Glenmark Pharmaceuticals has been granted final approval by the US Food & Drug Administration (FDA) for the hypertension drug nebivolol, for tablets of strengthen 2.5 mg, 5 mg, 10 mg and 20 mg. The approved product is the generic version of Bystolic tablet of Forest Laboratories Llc.
With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for nebivolol tablets. Therefore, with this approval, the company may be eligible for 180 days of generic drug exclusivity for nebivolol tablets.
Nebivolol, which belongs to a group of drugs called beta-blockers, is used to treat hypertension (high blood pressure). By lowering blood pressure, it lowers the risk of a stroke or heart attack.
Under the terms of the prior settlement agreement with Forest, Glenmark will be able to market and distribute its product under a license from Forest three months prior to the expiration of US patent, including any extensions and/or pediatric exclusivity, or earlier under certain circumstances.
According to IMS Health sales data for the 12 month period ending March 2017, the Bystolic tablets (2.5 mg, 5 mg, 10 mg and 20 mg) market achieved annual sales of approximately $ 1 billion.
Glenmark’s current portfolio consists of 116 products authorised for distribution in the US marketplace and approximately 68 ANDA’s pending approval with the US FDA. 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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