Financial Daily from THE HINDU group of publications
Friday, Apr 05, 2002
Dr Reddy's mum on Sanofi's plaint
HYDERABAD, April 4
DR Reddy's Laboratories Ltd has declined to comment on the charge levelled against it by the French drug maker - Sanofi-Synthelabo SA - that an application was filed by Dr Reddy's to manufacture a copycat version of its blockbuster blood-clot drug - Plavix.
Sanofi said on Wednesday that it would fight the Dr Reddy's company for filing an application with the US FDA to manufacture a generic version of Plavix.
The blood-thinning drug had sales of over $1.1 billion during last year in the US market.
In a complaint filed before the New York Federal Court last month, Sanofi alleged infringement of patents covering Plavix by a Canadian company - Apotex. The French drug-maker said it would initiate similar legal proceedings against Dr Reddy's also.
Plavix, indicated for the reduction of atherosclerotic events such as miocardial infarction, stroke and vascular death, currently accounts for a third of Sanofi's profits and is expected to contribute 40 per cent by 2005.
The three patents listed in the Orange Book pertaining to this drug were scheduled to expire during 2003, 2011 and 2014, respectively, with the main compound's patents expiring in 2011.
Dr Reddy's Laboratories, which had so far filed 19 abbreviated new drug applications (ANDAs) in the US generics market challenging patents of the inventors, was not willing to disclose whether it had filed an ANDA for the manufacture of Plavix in the recent past.
While Plavix did not figure in the list of 14 ANDAs filed by the Hyderabad pharma major till September 2001, it is not clear whether it was among the five ANDAs filed by the company during the quarter ended December 2001.
Having obtained the 180-day marketing exclusivity period for Fluoxetine 40mg capsules, the company recorded sales of $21 million (Rs 99.3 crore) during the third quarter of last fiscal.
Citing legal clearances to be obtained for making statements related to filing of ANDAs with the US FDA authorities, the spokesperson of Dr Reddy's told Business Line that the company was not prepared to comment on the complaint of Sanofi.
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