Dr. Reddy's Laboratories, on Friday, launched Clopidogrel tablets, a bioequivalent generic version of Plavix, a blood thinner drug, in the U.S. market with 180 days marketing exclusivity.
The company was among the first applicants to submit a substantially complete Abbreviated New Drug Application (ANDA) for Clopidogrel tablets in 300 mg capacity, according to a release issued by the company. It has secured approval of the U.S. Food and Drug Administration for 75 mg tablet, too.
The Plavix brand of Bristol Myers Squibb and Sanofi SA had sales of about $ 6.740 billion during 2012 calendar year in U.S., according to IMS Health.
Aurobindo Pharma, too, on Friday, announced that it had received USFDA's final approval to manufacture and market Clopidogrel tablets 75 mg.
The product falls under the cardio vascular therapeutic category and is indicated for the prevention of atherothrombotic events in patients who have had a myocardial infarction or ischaemic stroke or who have established peripheral arterial disease, a release said. The product was approved out of unit-three of the company's formulations facility in Hyderabad.