Blood-thinning drug logged $6 bn sales in 2006
HYDERABAD: Dr Reddy's Laboratories has got approval from the US Food and Drug Administration (FDA) to sell a generic version of blood-thinning drug Plavix sold by Bristol-Meyers Squibb and Sanofi-Aventis.
One of the top-selling drugs in the world, Plavix is the biggest grosser for Sanofi-Aventis, logging global sales of nearly $6 billion in 2006 and $3.77 billion in the US alone, as per figures from pharma market intelligence firm IMS Health.
Plavix (CLOPIDOGREL) is an antiplatelet agent used to reduce the risk of stroke or heart attack in patients with atherosclerosis.
However, Dr Reddy's will wait for another five to six months before it takes a call on the launch in the US markets pending the outcome of litigation between the BMS-Sanofi combine and Canadian drug-maker Apotex, a company official said.
Apotex was the first to launch generic clopidogrel in August 2006 at risk being the first to file a Para IV challenge on the patent and receive the FDA approval with a 180-days exclusivity.
The patent on Plavix is slated to expire in 2011 and has been in the market since 1997. It is marketed by BMS in the US and outside by Sanofi.
But the two companies were successful in blocking the continued marketing of generic clopidogrel by Apotex after it was launched in August 2006 in the 75 mg strength the same as approved for Dr Reddy's by the FDA on Monday. In June 2007 the US district court for the Southern New York had upheld the validity and enforceability of the patent on Plavix till 2011 and prevented Apotex from marketing the drug till the patent expired. Market analysts say Apotex made a killing on the drug in the 10 months that it was on the market.


