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Generic antibiotic cefuroxime axetil — Ranbaxy set to gain on Apotex's temporary loss

P.T. Jyothi Datta

NEW DELHI, May 16

FOR Canada-based drug major Apotex, it's a temporary loss on antibiotic cefuroxime axetil. But, it just may end up being Ranbaxy's gain.

Ranbaxy will be able to garner about three months more of exclusive sales for its generic version of cefuroxime axetil — a segment that Apotex would have eroded, if it too had launched its generic version of cefuroxime axetil, pharma industry analysts point out.

British drug-major GlaxoSmithKline (GSK) is the original patent holder for cefuroxime axetil, branded Ceftin by GSK. Thanks to a recent US Court ruling in favour of GSK — Apotex has been temporarily put out of the race to launch generic versions of Ceftin till July 2003. Ceftin is reported to have a global sales of $456 million.

Analysts told Business Line that Ranbaxy's generic version of Ceftin had already clocked "in excess of $40 million" in the first quarter for the year 2003. This robust figure could be on account of antibiotic sales peaking during the winter season. "While subsequent quarters may not be as robust - sales could have been eroded further if Apotex had launched its amorphous form of cefuroxime axetil. But with that proposal being shot down, Ranbaxy's crystalline form of the antibiotic could get an exclusive run for another three more months," the analyst said.

Cefuroxime axetil has been one of the significant players in scripting Ranbaxy's success in the US market, accounting for 14 per cent of its consolidated sales in 2002. Ranbaxy's generic version of Ceftin was launched in the US in March 2002 and it had posted a sales of over $115 million last year.

At present, it has garnered about 92 per cent of the prescription market, according to observers.

However, the domestic pharma major's efforts are bearing fruit, only after it slogged it out with GSK in the US courts. Ranbaxy Pharmaceuticals Ltd, a wholly-owned subsidiary of Ranbaxy Laboratories Ltd., had been locked in a legal battle with GSK over the generic version of cefuroxime axetil, since late 2000. Only in March 2002, Ranbaxy eventually launched its generic of Ceftin in the US , after a Washington court reversed a preliminary injunction granted by a lower court against Ranbaxy's drug in a patent violation suit filed by GSK.

Lupin is the other domestic drug major that has lost out, till July, as a result of the developments affecting Apotex. Lupin is the sole supplier of the key ingredient in Apotex's generic version of cefuroxime axetil. Earlier this month, the British drug major GSK had said that a US court had stated that its patents on the antibiotic would be violated by Apotex, if the latter launched its generic version before July, when the patents are set to expire.

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