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Tuesday, 22 October, 2002, 12:00 GMT 13:00 UK
Dr Reddy eyes landmark drug win
Dr Reddy's logo
Reddy's ranks as a pioneer in Indian pharmaceuticals
Fresh from an unsuccessful patent fight with AstraZeneca, Indian drug firm Dr Reddy is inching closer to muscling in on the market of another drugs giant.

Dr Reddy's plans to sell a version of Norvasc, Pfizer's blockbuster anti-hypertension drug, in the US have been boosted by news that the Food and Drug Administration has accepted its product for analysis.

The issue of an FDA "approvable letter", received by Dr Reddy, is a vital link in the chain, as many drugs never make it past that hurdle and into the approvals process.

But the company faces another patent battle first, as it waits to hear whether its new drug is sufficiently different from Norvasc to escape a patent extension granted to Pfizer.

First mover advantage

Under normal circumstances, the patent extension - from 25 August 2003 to January 2007 - would rule out the entry of a copy into the US market.

But Dr Reddy has filed a "new drug application", which allows for slight modifications of the recipe or the dosage.

If it wins, the company says, it will launch its drug on 26 August 2003, the day after the expiry of Pfizer's patent protection.

Never before has an Indian firm gone for a new drug deal, said SG Asia analyst Jesal Shah.

"Several things could have gone wrong as this is the first of its kind application by an Indian company," he said.

"But the fact remains that the company cannot launch the drug unless it wins a court case against Pfizer."

Losing out

Earlier this month, Dr Reddy was one of three companies found by a US court to have violated patents connected with one of AstraZeneca's key drugs, Prilosec, which treats gastric acid and stomach related diseases.

The ruling, against which the Indian firm is appealing, stopped the firm marketing its own version of Prilosec in the US.

Although Prilosec's patent has now run out, the usual cue for a massive free-for-all by generic drug makers, AstraZeneca managed to convince a judge that copies would violate subsidiary patents.

The drug earns AstraZeneca $6bn a year.

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