Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, the generic version of Bystolic Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg, of Forest Laboratories, LLC (Forest). 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 market1 achieved annual sales of approximately $1.0 billion.
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, 2.5 mg, 5 mg, 10 mg, and 20 mg. Therefore, with this approval, Glenmark may be eligible for 180 days of generic drug exclusivity for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.
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 No. 6,545,040, including any extensions and/or pediatric exclusivity, or earlier under certain circumstances.
Glenmark’s current portfolio consists of 116 products authorized for distribution in the US marketplace and approximately 68 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.