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Dr Reddy's files patent application in US

Our Bureau

HYDERABAD, May 30

DR Reddy's Laboratories has stated that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for `clopidogrel bisulfate' (CB) 75 mg tablets with Para IV certification on all listed Orange Book patents.

In a press release here on Thursday, Dr Reddy's also cited that it had notified Sanofi-Synthelabo Inc, upon which the latter had filed a lawsuit against the company alleging patent infringement. CB is the generic version of Sanofi-Synthelabo's Plavix.

CB is indicated for the reduction of atherosclerotic events (mycordial infraction, stroke and vascular death) in patients. The product had US brand sales of $1.1 billion during 2001 with an estimated annual growth rate of 52 per cent.

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