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Dr Reddy's gets tentative US nod for drugs

Drugmaker Dr Reddy's Laboratories Ltd said on Friday it had received tentative approvals from the US Food and Drug Administration 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 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. US 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 US 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 per cent at Rs 1610 on Friday ahead of the announcement. The Bombay benchmark index closed up 1.52 per cent.

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