Apr 11, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Columbia has granted a request of the Company's subsidiary, Teva Pharmaceuticals USA, Inc. that the U.S. Food and Drug Administration (FDA) relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal(R) (Risperidone) Tablets. Teva expects final approval with exclusivity on June 29, 2008. The brand product had annual sales of approximately $2.5 billion in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.
The decision may be appealed.
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