Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) obtained US Food and Drug Administration (FDA) approval for generic Risperdal on Friday, and has begun deliveries.
Brand Risperdal, an antipsychotic agent made by Johnson & Johnson (NYSE: JNJ) unit Janssen, had $78 million in sales in the 12 months through September 2008, according to IMS sales data. Teva has a 180-day exclusivity period for its generic Risperdal, Risperidone, as the first company to file an Abbreviated New Drug Application (ANDA) with Paragraph IV certification.
Last September, the US Court of Appeals for the District of Columbia vacated an April 2008 ruling, which granted Teva 180-day exclusivity for Risperidone.
Teva's share fell 1.2% on Nasdaq on Friday to $41.45. The share rose 0.6% at the opening on the TASE today to NIS 168.20, bucking the general market drop.
Published by Globes [online], Israel business news - www.globes-online.com - on February 1, 2009
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