FDA issued approval for 14 companies to manufacture and sell the first generic versions of GlaxoSmithKline’s (GSK) cardiovascular medication Coreg. The therapy earned $1.65 billion in U.S. sales for GSK in the 12-month period ending June 30.
The firms include Actavis Elizabeth, Apotex, Aurobindo Pharma, Caraco Pharmaceutical Laboratories, Dr. Reddy’s Laboratories, Glenmark Pharmaceuticals, Lupin, Mylan Pharmaceuticals, Ranbaxy Laboratories, Sandoz, Taro Pharmaceutical Industries, Teva Pharmaceuticals USA, Watson Laboratories, and Zydus Pharmaceuticals USA.
Coreg is indicated to treat high blood pressure, mild-to-severe chronic heart failure, and left ventricular dysfunction following a heart attack. All four strengths, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, will be sold as copycat versions.
FDA warns that the labeling of the generic products may differ from that of Coreg because patents and/or exclusivity protect parts of the original labeling.
GSK also sells a once-a-day formulation of the drug called Coreg CR. Patent protection for Coreg CR should run through 2023, according to the company.