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Glenmark greenlighted to market hypertension generic in US

Published on 30/05/17 at 12:16pm

Glenmark Pharmaceuticals has revealed it has been awarded final approval by the FDA to market hypertension treatment nebivolol, a generic version of Forest Laboratories’ Bystolic.

Glenmark reached a previous agreement with Forest which enables it to commercialise and distribute the drug three months before its US patent expiration, including any extensions and/or paediatric exclusivity. In addition, the firm may find itself eligible for 180 days generic exclusivity for nebivolol.

"With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was one of the first Abbreviated New Drug Application (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," noted Glenmark’s BSE filing.

Hypertension, also known as high blood pressure, can potentially present the risk of stroke or heart attack. Blood pressure is traditionally lowered through the use of beta blockers – a drug group of which nebivolol is a member. The approval is good news for Glenmark, who will be looking to capitalise on the $1 billion annual sales achieved by its originator product Bystolic last year; however, research released this week could cast a shadow as it is found that beta blockers have little to no effect on 95% of heart attack sufferers who have not also experienced heart failure.

Matt Fellows

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