Ranbaxy Laboratories Limited (RLL) and Teva Pharmaceutical Industries Ltd. announced today that Teva has begun commercially shipping Quinapril HCl tablets, 5 mg, 10 mg, 20 mg and 40 mg, manufactured, pursuant to Ranbaxy's ANDA No. 076607, which received final US FDA approval. The product will be sold in the US under the Teva label and marketed by Teva USA.

Quinapril HCl tablets are the AB-rated generic equivalent of Parke Davis ' antihypertensive agent Accupril tablets. The brand product has annual sales of approximately $555 million.

Teva is distributing the product as part of a supply and distribution agreement entered into by the two companies whereby Ranbaxy will manufacture and supply the product to Teva. Under the terms of this agreement, Teva and Ranbaxy will share in the profits. The launch follows Teva ' s relinquishment of its right to a 180-day period of marketing exclusivity for Quinapril HCl tablets.

In 2003, the FDA granted final approval for Teva ' s ANDA 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 4,743,450 patent. That decision is currently on appeal to the US Court of Appeals for the Federal Circuit.