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July 19, 2002 | 1210 IST
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Reddy's Lab files to market generic Lamisil in US

Indian drugmaker Dr Reddy's Laboratories said on Friday it had filed for approvals needed to market in the United States a generic form of Novartis' Lamisil used to treat athlete's foot.

A Dr Reddy's statement said the company had notified Novartis that it had filed the abbreviated new drug application (ANDA).

It also said Novartis had filed a lawsuit in a New York District court alleging infringement on the patent.

ANDAs are filed for permission to sell generic versions of drugs once their patents expire in the U.S. market.

"Dr Reddy's believes it has the first-to-file status for the product and if successful in its litigation would enjoy a 180-day marketing exclusivity," the statement said.

It has sought approvals from the US Food and Drug Administration for Terbinafine HCI tablets which are equivalent to 250 mg base.

Novartis' Lamisil tablets had sales of about $460 million in the United States last year, it said.

Dr Reddy shares were up 0.18 per cent at Rs 995 in morning trade while the Bombay benchmark was nearly flat.

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