Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical's gastric-acid pump inhibitor, Prevacid(R) (Lansoprazole) Delayed-release Capsules, 15 mg and 30 mg. The brand product had annual sales of approximately $3.4 billion in the United States for the twelve months ended September 30, 2007, based on IMS sales data.
Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of Delaware involving Teva's paragraph IV certification to U.S. Patent Nos. 4,628,098 and 5,045,321. A trial was held in November, at the end of which the Court indicated it anticipates it will issue a decision before the June 7, 2008 expiration of the mandatory 30-month stay of FDA approval associated with the patent litigation.
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