Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA)reported that the US District Court for the District of Columbia has granted a request of a Teva subsidiary - Teva Pharmaceuticals USA - that the US Food and Drug Administration grant Teva a 180-day exclusivity for a generic version of Janssen Pharmaceutical’s Risperdal Tablets. Teva expects final approval with exclusivity on June 29, 2008.
Risperdal is a treatment for schizophrenia, and is also used prescribed in certain cases of autism among children and bipolar disease among adults. 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.
Teva has sought to re-list the relevant patent and gain exclusivity on a generic version of the drug. The current decision does order the FDA to re-list the patent, although the decision may be appealed.
Shares in Teva closed up $0.62, or 1.34%, to $46.74 in Nasdaq trading on Friday, reflecting a market cap of $35.9 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on April 13, 2008
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