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Friday, Dec 17, 2004

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Teva to market Ranbaxy's drug in US

Our Bureau

New Delhi , Dec. 16

TEVA Pharmaceuticals, one of the world's largest generic companies, has launched Quinapril HCL tablets manufactured by Ranbaxy Laboratories Ltd in the US market.

Under an agreement, the product would be sold in the US under the Teva label and marketed by Teva USA. Also, the two companies would have share in the profit, said a statement from Ranbaxy. The launch follows Teva's relinquishment of its right to a 180-day period of marketing exclusivity for Quinapril HCL tablets used for treatment of hypertension.

Quinapril, which has an annual sale of about $55 million, is the AB-rated generic equivalent of Parke Davis' antihypertensive agent Accupril tablets

In 2003, the FDA granted final approval for Teva's ANDA (abbreviated new drug approval) for Quinapril HCl tablets. As the first company to file an ANDA with a Paragraph IV patent certification, Teva was awarded 180 days marketing exclusivity for this product.

Teva is currently enjoined from selling Quinapril HCl tablets under its own ANDA, following a court decision holding that Teva's product would infringe Pfizer's patent. That decision is currently on appeal to the US Court of Appeals for the Federal Circuit.

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