[Pharm-policy] INDIA DR REDDY'S GETS TENTATIVE US NOD FOR DRUGS

[James Love]

http://www.derwent.com/news/articles/article.cgi?year=2001&month=06&day=29&file=enu741gk&article=1


INDIA: INDIA DR REDDY'S GETS TENTATIVE US NOD FOR DRUGS. 

29/06/01: 
INDIA: INDIA DR REDDY'S GETS TENTATIVE US NOD FOR DRUGS. (REUTERS) 
BOMBAY, June 29 (Reuters) - Indian drugmaker Dr Reddy's Laboratories Ltd
said on Friday it had received tentative approvals from the U.S. Food
and Drug Administration (FDA) to market generic forms of two top-selling
drugs.

Dr Reddy's said in a statement it had received tentative approvals for
its generic versions of Eli Lilly's antidepressant Prozac (fluoxetine)
and AstraZeneca's ulcer drug Prilosec (omeprazole).

It said it had received tentative approvals for 40 mg capsules of the
drugs, adding it "believed it had first-to-file status" for both, giving
it the exclusive right to sell generic versions of both drugs for six
months if it prevails in patent violation cases.
   
Analysts see a $30-40 million opportunity for Dr Reddy's from the two
drugs in the six-month exclusive marketing period.

Eli Lilly claims Dr Reddy's has violated its patent on fluoxetine, and
AstraZeneca asserts the Hyderabad-based drugmaker has violated its
patent on omeprazole. U.S. generic firm Barr said on May 30 a court of
appeals had upheld an earlier decision allowing it to market its copycat
version of Prozac.

Dr Reddy's chief executive G V Prasad told Reuters his company's case
was similar to Barr's, raising hopes it too will be allowed to sell its
generic version in the United States.

A U.S. court has also ruled in Dr Reddy's favour in one patent dispute
against AstraZeneca over Prilosec. But a hearing on five other patents
related to the drug has been tentatively set for August.

Dr Reddy's said it plans to market fluoxetine through Pharmaceutical
Resources Inc .

It said Dr Reddy's, which is in the process of establishing its own
generic sales and marketing organisation in the United States, expected
to market omeprazole 40 mg capsules on its own.

Dr Reddy's shares closed up 2.06 percent at 1,610 rupees on Friday ahead
of the announcement. The Bombay benchmark index closed up 1.52 percent.



-- 
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030 fax 1.202.234.5176 mobile 1.202.361.3040