Dr Reddy's wins right to sell in US

MUMBAI - Leading Indian pharmaceutical company Dr Reddy's Laboratories announced on Wednesday that it has won an important court ruling in the United States against the world's top drugmaker, Pfizer Inc, that will allow it to sell a version of Pfizer's hypertension drug, Norvasc, on the US market.

Dr Reddy's now says that it will be in a position to launch the drug next August after final US regulatory approvals and the expiry of what it called Pfizer's pediatric exclusivity rights on the drug. Pediatric exclusivity is a six-month period of sole marketing rights given to a drug's originator if it establishes safety for use in children.

A New Jersey district court dismissed Pfizer's plea on the grounds that a patent extension on Norvasc until 2007 did not cover Dr Reddy's amlodipine maleate product, Reddy's said in a statement. Amlodipine maleate differs chemically from the amlodipine besylate form of Pfizer's anti-angina and hypertension drug, which had sales of US$2.5 billion in 2001.

A company official said that the firm could now look for an acquisition or alliance in the US to help market the drug. Amlodipine now has the potential to become Dr Reddy's biggest product in the US, ahead of a generic copy of Eli Lilly's antidepressant Prozac.

Dr Reddy's filed for an application last December to market the drug under section 505 b(2) of the Federal Food, Drug and Cosmetic Act. And the victory is likely to open the door for other Indian companies to sell modified generics in the US.

Indian firms have traditionally focused on making cut-price generics for the US market, or exact copies of drugs that have gone off patent. Dr Reddy's has been one of the top proponents of this strategy, having sold more than $100 million worth of a generic version of Eli Lilly's anti-depressant Prozac since August 2001.

(Asia Pulse)