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Teva to market generic Risperdal.

A U.S. District Court judge in Washington, has ruled that Teva Pharmaceutical Industries Ltd. has the right to make and sell a generic version of Risperdal (risperidone). Unless the ruling is challenged, Teva can begin exclusive sales of risperidone on June 29, the date Johnson & Johnson's patent for Risperdal expires. The FDA and generic pharmaceutical manufacturer Mylan Inc. had argued that Teva should not be allowed to have exclusive rights to the generic version of the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the meantime, J&J and its partner Alkermes Inc. have applied to the FDA to sell a long-acting form of the drug, Risperdal Consta, for frequently relapsing bipolar disorder, defined as four or more manic episodes in the previous year. Alkermes estimates that 10%-20% of people with bipolar disorder worldwide meet that criterion.
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Title Annotation:POLICY & PRACTICE.
Author:Ault, Alicia
Publication:Clinical Psychiatry News
Date:May 1, 2008
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