Teva gets FDA approval for generic Aciphex

Aciphex, made by Eisei, has $1.3 billion in annual sales.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has obtained US Food and Drug Administration (FDA) marketing approval for Rabeprazole Sodium Delayed-Release Tablets, 20 mg. Teva has been awarded a 180-day marketing exclusivity period.

Rabeprazole Sodium is the generic version of Aciphex, an acid pump inhibitor made by Eisai of Japan. Aciphex has $1.3 billion in annual sales, based on IMS sales data.

In February 2006, Teva obtained conditional marketing approval for the drug. Teva is currently in patent litigation concerning Aciphex in the US District Court for the Southern District of New York. The lawsuit was filed shortly after Teva applied for marketing approval in the third quarter of 2003. Eisei claims that the patent expires in 2013. A hearing is due on March 5.

Published by Globes [online], Israel business news - www.globes.co.il - on February 22, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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