Teva Receives Court Ruling Awarding Exclusivity For Generic Risperdal(R)

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Schizophrenia;  Bipolar;  Autism
Article Date: 14 Apr 2008 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

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® (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.

This decision may be appealed.

About Risperdal®

RISPERDAL® (risperidone) is used for:

• The treatment of irritability associated with autistic disorder in children and adolescents.
• The control of schizophrenia in adults, by delaying relapse and controlling symptoms.
• The treatment of bipolar mania associated with Bipolar I Disorder in adults, providing effective control of mania symptoms.

For further information please go to http://www.risperdal.com/risperdal/

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe.

Teva Pharmaceutical Industries Ltd.