Teva gets FDA nod for generic Ortho Tri-Cyclen

Annual US sales of the drug are about $400 million.

Generic pharmaceuticals company Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) said that the US Food and Drug Administration (FDA) has approved Teva's application to sell a generic version of oral contraceptive Ortho Tri-Cyclen Lo.

Based on IMS sales data, US sales of Ortho Tri-Cyclen Lo were about $400 million for the twelve months ended March 31.

Teva's drug, a generic version of Ortho McNeil Janssen’s oral contraceptive Ortho Tri-Cyclen Lo, is called Tri-Lo Sprintec. Shipments have already begun.

Teva said that as the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, it has been awarded a 180-day period of marketing exclusivity. Teva is currently involved in patent litigation concerning the product in the US District Court for the District of New Jersey.

In April, Teva received FDA authorization to develop a generic version of birth control pill Yaz, made by Bayer Healthcare Pharmaceuticals.

Shares in Teva rose 0.4% to $49.34 yesterday, giving a market cap of $42.09 billion.

Published by Globes [online], Israel business news - - on July 1, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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