Glenmark Pharmaceuticals has received final approval from the US health regulator for a 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 (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,” 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.
Glenmark added that it may be eligible for 180 days of generic drug exclusivity for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg.
Glenmark said under the terms of the prior settlement agreement with Forest, it 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 paediatric exclusivity, or earlier under certain circumstances.
According to IMS Health sales data for the 12 months to March 2017, the Bystolic tablets achieved annual sales of approximately USD 1 billion, Glenmark said.
The company’s current portfolio consists of 116 products authorised for distribution in the US marketplace and 68 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA. Glenmark Pharmaceuticals shares were trading at Rs 613.25 in on the BSE, down 1.18 per cent on BSE.