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Par ships first generic version of J&J drug


WOODCLIFF LAKE, N.J. Par Pharmaceutical Cos. has begun shipping its generic version of a drug used to treat schizophrenia and bipolar disorder.

The company announced Tuesday the shipment of risperidone ODT in the 0.25-mg, 3-mg and 4-mg strengths. The drug is used in adults as a stand-alone treatment for schizophrenia and as a combination, with lithium or valproate, for the treatment of manic and mixed episodes in bipolar I disorder.

The drug is a generic version of Johnson & Johnson’s Risperdal M-TAB, which had sales of $89 million last year, according to IMS Health data. As the first company to file an approval application with a paragraph IV certification, Par has six months of market exclusivity, though J&J retains exclusivity for the use of the drug in children.

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