Dr Reddy’s Laboratories has succeeded in developing a copycat or 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.
"Dr Reddy's asserts the invalidity or non-infringement of three patents for Lipitor which, including the six-month pediatric exclusivity period, expire between 2013 and 2017," said Pfizer. Dr Reddy's has not challenged a related patent on 'enantiomer', which expires in June 2011, Pfizer added.
An e-mail sent to the Dr Reddy's spokesperson did not elicit any response.
Analysts, however, said it's an important development, but 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 plans seem to be to have the first-mover advantage in some of the supplementary or combination products of this drug. But even in that case, Dr Reddy's is not going to launch its generic before 2013. By that time, there will be many players in the market," said a senior industry analyst, who did not want to be quoted due to business tie-ups of his firm with Pfizer, Ranbaxy and Dr Reddy's.
Ranbaxy will launch its drug only by November 30, 2011, as per the terms of an out of court settlement the company entered into with Pfizer after Ranbaxy's takeover by Daiichi Sankyo. Ranbaxy was fighting patent litigations on Lipitor with Pfizer in various geographies since 2003. The basic patent of Lipitor expires in the US in 2010 and the related sub-patent expires in 2011. Then various process and crystalline form patents will expire by 2016 and 2017. A combination drug patent of Lipitor is also valid till 2018.
Lipitor is the largest ever selling drug and had global sales of $2.9 billion for the three months ended September 27 and $8.3 billion for the last nine months, a drop of 11 per cent over the previous corresponding year.
Sources said companies such as Israel-based Teva also has developed a generic for Lipitor. The Pfizer filing said remers Urban Development Company, Canadian company Pharmascience and Genpharm had also filed for marketing generic versions of Lipitor. Recently, Pfizer settled the patent challenges with Pharmascience and Genpharm.
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.