FDA approves 7 companies to sell generic Plavix in pharmacies immediately
(CBS/AP) The popular blood thinner Plavix is going generic, the Food and Drug Administration said Thursday, giving lower cost options for the people who take the blood thinner to reduce their risk for stroke and heart attack.
The patent for Plavix, the world's second-best-selling medicine just expired, and the FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose.
The agency also gave four generic drugmakers approval to sell a 300-milligram dose of Plavix that's given as initial treatment to patients who have just had a heart attack.
Plavix is taken by millions of people every day to prevent heart attacks and strokes by preventing platelets in the blood from clumping together. Brand-name Plavix is marketed jointly by Bristol-Myers Squibb Co. and Sanofi SA. They're now offering coupons giving a big discount off the brand price, which is currently about $200 per month.
Patients who sign up for the Plavix Choice Card program at http://www.plavix.com will get a 30-day supply for no more than $37 through the end of the year, if they are paying with cash or have private insurance. The program is not open to people covered by state or federal health programs, including Medicare and Medicaid, or to residents of Massachusetts, where such programs are prohibited.
Bristol-Myers and Sanofi had been splitting nearly $9 billion a year in revenue from Plavix the last several years, but that started declining in 2011 after the drug's patent expired in several European countries and other major markets.
That revenue will decline more quickly with generic versions now available in the U.S., which accounts for close to half of all prescription drug sales globally.
According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals. The larger dose will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.
The generics should be available in pharmacies immediately. Among them, Walmart and Sam's Club pharmacies nationwide will begin selling generic Plavix on Saturday for about $40 a month or a $10 co-pay with insurance.
The FDA has more information on generic drugs.
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