Teva gets tentative approval for Aciphex generic

By E. Janene Geiss

Philadelphia, Feb. 16 - Teva Pharmaceutical Industries Ltd. said Thursday that the Food and Drug Administration has granted tentative approval for the company's abbreviated New Drug Application for 20 mg rabeprazole sodium delayed-release tablets.

Upon final approval, the tablets will be the AB-rated generic equivalent of Eisai's acid pump inhibitor Aciphex tablets, according to a company news release.

The brand product has annual sales of about $1.2 billion, officials said.

Teva is in patent litigation concerning this product in the U.S. District Court for the Southern District of New York. A suit was brought against Teva in November 2003 involving Teva's paragraph IV certification to U.S. Patent No. 5,045,552. A trial date has not been set, officials said.

Final approval of this aNDA is expected upon the earlier of a favorable decision in the case or expiry of the mandatory stay of approval in February 2007.

Teva is a Jerusalem-based pharmaceutical company that develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

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