Dr Reddy's, Aurobindo get US nod for generic cardiac drug
Dr Reddy's Laboratories and Aurobindo Pharma have received US Food and Drugs Administration (FDA) approval to sell a generic version of Clopidogrel tablets, the two companies said on Friday.
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Dr Reddy's Laboratories,
Aurobindo Pharma and others have received US Food and Drugs Administration (FDA) approval to sell a generic version of Clopidogrel tablets, the two companies said on Friday.Clopidogrel is a copy of Plavix, marketed by Sanofi-Aventis, and is used to prevent acute coronary conditions in patients who have recently had heart attacks or strokes.Eight generic drug makers, which include Apotex, Aurobindo, Dr Reddy's Mylan, Roxanne, Sun Pharma, Teva and Torrent Pharma have received go aheads to sell the tablet in 75 mg strength and four generic companies -- Dr Reddy's, Gate, Mylan and Teva can also sell the drug in higher 300 mg strength, analysts say.The Plavix brand had US sales of about USD 6.7 billion for the year ended March 2012, the companies said citing IMS Health data. It was for long the largest selling drug in the US market after Pfizer's cholesterol lowering drug Lipitor, whose patents expired last year.Dr Reddy's said it launched the product from Friday.Hitesh Mahida, an analyst with Fortune Equity Brokers expects Dr Reddy's to generate USD 12 million in sales during the exclusivity period. "We are skeptical of Dr Reddy's ability to gain market share in the 300 mg version since it is only sold in Hospitals wherein it doesn't have any significant presence," he said.Mahida expects Sun, Aurobindo and Torrent to generate sales of USD 30-35 million from the drug sales.While Sun Pharma and Aurobindo shares were up 0.5-1%, Dr Reddy's was down 0.1% and Torrent fell 1.6% in afternoon trade on NSE.Nachiket Kelkar
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