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Glaxo files to stop Ceftin generic using Lupin drug

GlaxoSmithKline Plc said on Wednesday it had filed for a preliminary injunction seeking to prevent Canada's Apotex from selling a generic version of GSK's Ceftin antibiotic in the US market.

Apotex buys the key ingredient in its generic version, cefuroxime axetil, from Indian drugmaker Lupin Ltd. Its chairman told Reuters earlier in the day that he expected the Canadian drugmaker to start selling the generic drug soon after getting approvals from U.S. regulators.

But a GSK spokeswoman said her company had filed an injunction to try and stop Apotex from launching its copy.

"We have recently filed a request for a preliminary injunction at the US district court in Chicago," spokeswoman Mary Anne Rhyne told Reuters from GSK's US headquarters in North Carolina.

"The allegation is that Apotex would be infringing our patent on the amorphous form of Ceftin, the patent for which expires in July 2003," she said. "This is part of a larger patent litigation suit pending against Apotex from 2000."

Lupin has already shipped $3.5 million worth of cefuroxime axetil to Apotex, Gupta said.

"We are expecting approvals from the US Food and Drug Administration for our product soon," he said.

NOT THE ONLY GENERIC

Lupin, India's number one producer of anti-tuberculosis drugs, also makes antibiotics such as cephalosporins, a category in which Ceftin falls.

Gupta said Lupin would export $12 million worth of the cefuroxime bulk drug in the year to March 2003. He said it would export $13 million worth of a cardiovascular drug lisinopril to Apotex and other partners in the United States during the year.

Lupin reported on Monday its net profit for the past year to March rose 20.3 per cent to Rs 721.8 million ($14.7 million) on sales that rose six per cent to Rs 9.57 billion.

Its shares ended up 4.81 per cent at Rs 114.45 in afternoon trade on the Bombay Stock Exchange, whose benchmark index ended down 0.35 per cent.

India's largest drugmaker by sales, Ranbaxy Laboratories, already sells generic Ceftin in the United States after winning a patent battle with GlaxoSmithKline and has eaten into the British drugmaker's market share there.

The price of the drug could fall after the entry of Apotex's generic version due to competition, analysts said.

Ranbaxy's shares closed down 2.79 per cent at Rs 777.55.

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