Sales Decline Expected for Plavix Brand

On May 17, 2012, the FDA approved generic versions of the blood thinning drug Plavix® (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.  Faced with the expected influx of cheaper generic alternatives, Bristol-Myers Squibb, which sells Plavix in the United States has said it no longer plans to actively promote the drug.

Currently, clopidogrel  is FDA-approved to treat patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease).  Clopidogrel has a boxed warning to alert health care professionals and patients that the drug may not work well for those with certain genetic factors that affect how the body metabolizes the drug.

About 80 percent of the prescriptions written in the United States are now filled with generic drugs.  In the 15 years since it entered the market, Plavix generated $42.8 billion in sales for Bristol-Myers, according to IMS Health, a health care services company.

Dr. Reddy’s Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals gained FDA approval for 300 milligram (mg) clopidogrel.  Additionally, Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals received approval for 75 mg clopidogrel.

With these generics ready to enter the market throughout the next six months, the Plavix branded sales in the U.S. that amounted to about $6.74 billion for the twelve months ending March 31, 2012, will dramatically decline.