UPDATE:FDA Approves Generic Versions Of Blood-Thinning Drug Plavix
May 17 2012 - 3:55PM
Dow Jones News
The U.S. Food and Drug Administration on Thursday approved
generic versions of blood-thinning drug Plavix.
Plavix, marketed by Bristol-Myers Squibb Co. (BMY) and Sanofi
(SNY), is used to ward off heart attacks and strokes in people with
cardiovascular disease, and was among the best-selling drugs in
history. The drug's $6.8 billion in U.S. sales last year, as
tallied by IMS Health, ranked second behind Pfizer Inc.'s (PFE)
Lipitor, which is used to treat high cholesterol. Plavix's U.S.
patent expired Thursday, clearing the way for generic versions of
the drug, which carries the generic name clopidogrel.
The FDA said it approved Dr. Reddy's Laboratories Ltd. (RDY,
500124.BY), Gate Pharmaceuticals, Mylan Pharmaceuticals and Teva
Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) to sell a
300-milligram dose of clopidogrel. Teva and Mylan have also been
granted approval to sell a 75-milligram dose of the drug along with
Apotex Inc., Aurobindo Pharma Ltd. (524804.BY), Roxane
Laboratories, Sun Pharmaceutical Industries Ltd. (524715.BY), and
Torrent Pharmaceuticals Ltd. (500420.BY).
Clopidogrel is FDA-approved to treat patients who have recently
had a heart attack or stroke, or have partial or total blockage of
an artery, the FDA said.
In a statement, Mylan said it would beginning shipping both
doses of clopidogrel immediately. The company also said it had 180
days of exclusivity to sell the 300-milligram version of
clopidogrel because it was the first company to file for FDA
approval of that dose.
Bristol-Myers Squibb and Sanofi are offering discounts to
patients who want to continue using branded Plavix.
Bristol and Sanofi are offering a Plavix Choice Program to cap
monthly, out-of-pocket costs to $37 starting Thursday.
Without the discount, monthly out-of-pocket costs could rise to
$100 for branded Plavix due to changes by health plans designed to
encourage use of generic Plavix. The program is open to eligible
cash-paying and commercially insured patients. Patients can choose
to receive the drug at a pharmacy or have it shipped directly.
Bristol-Myers said it's not widely promoting Plavix Choice, but
has reached out to current Plavix patients to let them know it's
available.
"It is a program that BMS and Sanofi are providing for patients
who wish to continue on brand-name Plavix once generics become
available," said Bristol spokeswoman Laura Hortas.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
-Peter Loftus contributed to this article.
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