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Ranbaxy set to launch Augmentin in January

Our Bureau

NEW DELHI, Dec. 10

LITIGATION notwithstanding, Ranbaxy Laboratories Ltd (RLL) is set to launch a generic version of GlaxoSmithKline's (GSK) blockbuster antibiotic Augmentin, in the US in January 2003. The patent on the drug expires on December 24, 2002.

This development comes even as GSK is leaving no stone unturned to retain its exclusivity on Augmentin, on the grounds that it has valid patents in the US, till 2017. The most recent of these embittered battles being, hauling generic drug-makers to court on alleged charges of using stolen bacteria to make their generic versions of the drug. Dr Brian Tempest, Ranbaxy's President, is said to have told agencies that Ranbaxy had decided to start selling its drug after a careful evaluation of the legal situation.

In its communiqué issued here on Tuesday, RLL said that it would launch its generic co-amoxyclav, a generic version of GSK's Augmentin in a combination form, in January 2003 in the US market. RLL had earlier received final approval from the US Food and Drug Administration to manufacture and market two copycat versions, Amoxicillin and Clavulanate Potassium Tablets USP, 875mg/125 mg (base) and 500mg/125 mg (base).

Based on bio-equivalent studies, the formulation has been deemed to be bio-equivalent and therefore, therapeutically equivalent to the listed drug i.e., Augmentin Tablets, 875 mg and 500 mg of GlaxoSmithKline, RLL said.

Other competitors in this segment, also slated to launch their generic versions of Augmentin in early 2003, are Geneva Pharmaceuticals, the generic arm of Swiss pharma major Novartis, and Israel's Teva Pharmaceutical Industries. A fourth drug-maker, Slovenia's Lek, acquired by Novartis in November, is also expected to launch generic Augmentin in early 2003.

According to Ranbaxy, GSK's Augmentin tablets had clocked sales of $1.18 billion in the 12 months up to June.

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