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Dr Reddy's develops generic version of Pfizer's Lipitor

Dr. Reddys Laboratories Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 500124 | NSE: DRREDDY

09 Nov 2009 Evaluate

Dr Reddy’s Laboratories has succeeded in developing a generic version of Pfizer’s Lipitor, the world's largest selling drug which has sales of over $10 billion. With this, the Indian drug maker has joined the club of only a few generic companies hoping to grab a share of the cholesterol-lowering drug's market when its patent expires from next year. The only Indian company in the club so far has been Ranbaxy.

Dr Reddy's Laboratories and its US subsidiary informed Pfizer last month about the filing of an application with the US Food and Drug Administration (FDA) seeking approval to market a generic version of Lipitor, Pfizer said yesterday in a regulatory filing to the US Securities and Exchange Commission (SEC). Under the US rules for generic drugs, when a patent is challenged, the innovator is informed about it. The innovator has to sue the company within 45 days to ban approval for the next 30 months. Pfizer did not specify whether it would sue Dr Reddy's in a US court.

The gains for Dr Reddy's might not be as big as that of Ranbaxy, which was the first company to develop a generic for Lipitor and held a six-month exclusive sales right in the US market upon patent expiry by next year. Dr Reddy's is not going to launch its generic before 2013. By that time, there will be many players in the market.

Dr Reddy's, the second largest domestic drug maker after Ranbaxy in terms of sales, is planning to launch six to seven new generics in the US in 2009-10, including the generic of omeprazole, AstraZeneca's brand Prilosec for treating stomach ulcers. The company had sales of Rs 430 crore for the second quarter of 2009-10 from North America, a growth of 36 per cent over the previous year. It markets close to 80 generic drugs in the US market and another 62 are pending for approval with the USFDA. Of this, 27 applications challenge innovator patents and the company is believed to have 16 first-to-file status or first to market opportunity upon patent expiry.

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Dr. Reddys Lab Share Price

1232.00 19.65 (1.62%)

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Company Name	CMP
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Dr Reddy's develops generic version of Pfizer's Lipitor

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