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Teva Asks FDA To Relist Risperdal Patent And Restore 180-Day Exclusivity

Executive Summary

J&J's delisted Risperdal patent should be returned to the "Orange Book" and 180-day exclusivity restored to Teva Pharmaceuticals, the generic company states in a petition to FDA

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FDA issues a correction for mistakenly approving a generic form of Johnson & Johnson's antipsychotic Risperdal (risperidone). The March 4 posting on the agency's Web site states, "The application for Risperidone Tablets from Ranbaxy was incorrectly listed as approved in Drugs@FDA. This application is not approved. We have corrected Drugs@FDA." Risperdal's primary patent will expire in June 2008 after a six-month pediatric exclusivity extension, while the rapid-dissolving tablet has protection extending to 2017 (1"The Pink Sheet," Aug. 27, 2007, p. 5). Ranbaxy, along with Par and Roxane, have tentative approval for the oral solution, while Mylan and Pliva (Barr) have tentative approval for the tablets

FDA mistakenly approves generic Risperdal

FDA issues a correction for mistakenly approving a generic form of Johnson & Johnson's antipsychotic Risperdal (risperidone). The March 4 posting on the agency's Web site states, "The application for Risperidone Tablets from Ranbaxy was incorrectly listed as approved in Drugs@FDA. This application is not approved. We have corrected Drugs@FDA." Risperdal's primary patent will expire in June 2008 after a six-month pediatric exclusivity extension, while the rapid-dissolving tablet has protection extending to 2017 (1"The Pink Sheet," Aug. 27, 2007, p. 5). Ranbaxy, along with Par and Roxane, have tentative approval for the oral solution, while Mylan and Pliva (Barr) have tentative approval for the tablets

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