Teva loses generic Risperdal exclusivity

Teva began marketing generic Risperdal July 1.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) reports that, on Friday, the US Court of Appeals for the District of Columbia has vacated an April 2008 ruling, which granted Teva 180-day exclusivity for Risperidone, its generic version of Risperdal, a treatment for schizophrenia and some symptoms of autism made by Johnson & Johnson (NYSE: JNJ) unit Janssen.

The court ruling means that the US Food and Drug Administration (FDA) may not approve Teva's abbreviated new drug applications (ANDA) for the drug. Teva will seek a stay of the court decision pending further appeals.

On July 1, Teva began marketing generic Risperdal. The branded drug has $2.6 billion in annual sales in the US, based on IMS sales data. Analysts predicted that Risperdal sales could add up to $0.30 in Teva's earning per share for 2008.

In April, the US District Court for the District of Columbia granted the request of Teva subsidiary Teva Pharmaceuticals USA Inc. to market generic Risperdal, a ruling that overturned the FDA's previous refusal to grant ANDA status to Teva for the drug. The court ordered the FDA to re-register the patent for Risperdal, a ruling that the FDA appealed and won on Friday.

Published by Globes [online], Israel business news - - on September 14, 2008

© Copyright of Globes Publisher Itonut (1983) Ltd. 2008

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