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Ranbaxy, DRL get key FDA approval

Ranbaxy, DRL get key FDA approval
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First Published: Thu, Apr 26 2007. 12 12 AM IST
Updated: Thu, Apr 26 2007. 12 12 AM IST
New Delhi: Ranbaxy Laboratories Ltd and Dr Reddy’s Laboratories Ltd, India’s top two drug makers, have been granted approvals to sell copies of two large-selling medicines in the US by that country’s pharmaceuticals regulator, the Food and Drugs Administration.
While Ranbaxy has been allowed to exclusively sell a version of the $1.19 billion (Rs4,879 crore) cholesterol drug Pravastatin—sold as Pravachol by Bristol-Myers Squibb Co., Dr Reddy’s along with 12 other firms can sell off-patent copies of Sanofi-Aventis SA’s sleeping pill, Ambien, which sold worth $2.1 billion in 2006.
The FDA gave Ranbaxy its approval to sell Pravastatin in the 80mg dosage with limited competition in the US. Bristol-Myers Squibb’s sales of the drug in that dosage were $209 million in 2006. The exclusivity period kicks in immediately and Ranbaxy, in a statement, said it will be manufacturing and marketing the drug from a US-based unit.
Dr Reddys, on the other hand, will be fighting for market share with 12 other non-patented drug makers in the US, including Mylan Laboratories Inc., Teva Pharmaceutical Industries Ltd, Roxane Laboratories Inc., Watson Laboratories Inc., Apotex Inc., and Synthon Pharmaceuticals Inc. besides Ranbaxy.
Dr Reddy’s said it had received approval for 5mg and 10mg of Zolpidem Tartrate tablets and would begin selling the product immediately.
The impact on the businesses of Dr Reddy’s and Ranbaxy will be small, analysts said. Pravachol, which went off patent in April 2006, has had 10mg, 20mg and 40mg generic versions introduced since then by Watson Phamaceuticals Inc., which was authorized by Bristol-Myers Squibb to do so, and Teva. Ranbaxy could make about $25 million from Pravastatin sales, an analyst with the local unit of a UK brokerage said. Nitin Aggarwal, pharmaceutical analyst with Mumbai-based SSKI Securities Pvt. Ltd said the $25-million estimate might be optimistic. “This is unlikely to be a big drug. As the other dosages have already been selling in the market for almost a year, Ranbaxy will not be able to charge a premium on its product,” he said.
Last year, Ranbaxy and Dr Reddy’s had seen a surge in revenues aided by selling versions of Simvastatin, another cholesterol drug, sold as Zocor by Merck & Co. Ranbaxy made $60 million from selling the drug between June and December last year and Dr Reddy’s added $66 million to its turnover from the drug’s sales.
Shares of Ranbaxy closed 5.71% higher at Rs369.10 each and Dr Reddy’s fell by 0.4% to close at Rs711.15.
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First Published: Thu, Apr 26 2007. 12 12 AM IST
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