Glenmark Pharmaceuticals has received final approval from FDA for generic version of Bystolic tablets, used in the treatment of hypertension.
“Glenmark Pharmaceuticals USA has been granted final approval by the US Food & Drug Administration (FDA) 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,” Glenmark Pharmaceuticals said in a BSE filing
“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,” the company said.
With this approval, Glenmark t it may be eligible for 180 days of generic drug exclusivity for Nebivolol tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.
Glenmarkwill be able, under the terms of the prior settlement agreement with Forest, to market and distribute its product under a licence from Forest three months prior to the expiration of US patent No 6,545,040,
According to IMS Health sales data for the 12 months to March 2017, Bystolic tablets achieved annual sales of approximately $1 billion, Glenmark said.