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.
