Tentative FDA OK for Teva's generic rabeprazole

Israel's Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted tentative approval for the Abbreviated New Drug Application for rabeprazole sodium delayed-release tablets, 20mg. On final approval, Teva's product will be the AB-rated generic equivalent of Japanese drugmaker Eisai's acid pump inhibitor Aciphex. The brand product has annual sales of approximately $1.2 billion.

Teva says it is currently in patent litigation concerning this product in the US District Court for the Southern District of New York. A suit was brought against the Israeli firm in November 2003 involving Teva's paragraph IV certification to US patent no 5,045,552. A trial date has not been set.

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