FDA OKs multiple companies to sell generic Plavix

TRENTON, N.J. (AP) -- Patients taking the popular blood thinner Plavix now have the option of getting a less-expensive pill, following the approval Thursday of the first generic versions in the U.S.

That's because the patent for Plavix, the world's second-best-selling medicine, just expired. Plavix is taken by millions of people every day to prevent heart attacks and strokes, by preventing platelets in the blood from clumping together.

The Food and Drug Administration said it has given 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.

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 about $200 per month.

Patients who sign up for the Plavix Choice Card program at 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 Saturday, for about $40 a month or a $10 co-pay with insurance.


Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma

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