Glenmark Pharmaceuticals Receives ANDA Approval For Nebivolol Tablets


Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. 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 [Forest]. 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 U.S. Patent No. 6,545,040, 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 market1 achieved annual sales of approximately $1.0 billion.

For Quick Trial – 8962000225 ✔ 
or mail us here: info@ways2capital.com
or visit http://www.ways2capital.com
✆ - 0731-6626222 | Toll Free - 1800-3010-2007 ✔ 
Give a Missed Call for Free Trial - 09699997717 ✔
Share on Google Plus

About Suhani Varma

This is a short description in the author block about the author. You edit it by entering text in the "Biographical Info" field in the user admin panel.

0 comments: