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Ranbaxy says drug close to US approval

Drugmaker Ranbaxy Laboratories expects its generic version of a GlaxoSmithKline drug to be recognised by a US authority in July, a company spokesman said on Thursday.

Spokesman Paresh Chaudhry said the expected approval by the US Pharmacopoeia, a compendium of drugs that specifies standards for their contents, would strengthen prospects for the drug's launch in the United States.

GlaxoSmithKline Plc asked the US Food and Drug Administration last year not to approve Ranbaxy's version of the drug, cefuroxime axetil, and won a preliminary court injunction to prevent its launch on grounds of patent infringement.

Ranbaxy's version of the drug is slightly different from the original GlaxoSmithKline product as it has crystalline content while the British firm's drug is essentially free of this.

"We've had discussions with the publishers of the US Pharmacopoeia and feel it's likely that the Pharmacopoeia's supplement in July is likely to carry our version of cefuroxime," Chaudhry said.

The recognition would boost Ranbaxy's chances of launching the product in the lucrative US market, analysts said.

"If this (inclusion) were to come through, it would imply that Ranbaxy's drug is equivalent to GlaxoSmithKline's in terms of its activity in the body," said SG Asia analyst Jesal Shah.

"It's difficult to say what will happen in court but this will certainly strengthen Ranbaxy's case," he added.

Shah estimated $50 million sales in the year after launch.

"We think the US FDA can proceed with the clearance of our drug now and the recognition removes a bottleneck," Chaudhry said.

Hearings in the court case ended on April 3, and Ranbaxy is awaiting the court's opinion, he said.

The case has led to a six-month delay so far in Ranbaxy's launch.

Ranbaxy, India's largest drugmaker by sales, specialises in identifying drugs that are going off patent in the United States and tries to get its versions into that lucrative market quickly.

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