Pharma major, Dr Reddy's Laboratories announced today that it has launched Clopidogrel tablets, USP, a bioequivalent generic version of Plavix in the US market.
The Abbreviated New Drug Application (ANDAs) for clopidogrel tablets USP, 75 mg & 300 mg are approved by the United States Food & Drug Administration (USFDA), a company statement said.
Dr Reddy's Laboratories was among the first applicants to submit a substantially complete ANDA for Clopidogrel tablets USP, 300 mg with a Paragraph IV certification, and was awarded 180 days of marketing exclusivity for this strength. The Plavix brand had US sales of approximately USD 6.740 billion for the most recent twelve months ending March 2012 according to IMS Health. Dr Reddy's Clopidogrel tablets USP, 75 mg are available in bottle count sizes of 30, 90 and 500 and Clopidogrel tablets USP, 300 mg are available in blister packs of 30's count, the release said.
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