The Hindu Business Line : Ranbaxy wins 2 patent claims for clarithromycin in US

RANBAXY Laboratories Ltd today said that it had won two out of the three patent claims for Clarithromycin 1000 mg extended release (ER) drug used in the treatment a wide variety of bacterial respiratory tract infections including chronic bronchitis and acute maxillary sinusitis.

Clarithromycin is the generic version of Biaxin, a drug manufactured by Abbott Laboratories.

While the US District Court for the District of Northern Illinois ruled two patent claims in favour of the company, it lost the third one that pertains to labelling. The company can now launch the 1,000 mg extended release drug in the US only after amending the label.

Ranbaxy, in the statement, said that the ruling also provides clarity on the company's position with regard to 500 mg extended release tablets.

"While this decision does not apply to the 500 mg ER product, the court's ruling provided a clear direction for changes in Ranbaxy's labelling to make both products non-infringing," it said. The company will hold talks with the US Food and Drug Administration to amend its labelling for the yet-to-be approved 500 mg tablet.

According to Mr Malvinder M. Singh, President & Executive Director, Ranbaxy, "The ruling on Clarithromycin 1000 mg ER does not impact Ranbaxy's plan to introduce Clarithromycin 500 mg ER which, subject to USFDA approval, remains on-course."

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