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Monistat 1 patent suit

This article was originally published in The Tan Sheet

Executive Summary

Perrigo has been dismissed from a lawsuit relating to its filing of an abbreviated new drug application for a generic version of McNeil's miconazole nitrate vaginal cream, 2 percent, and suppository, 1.2 grams, the Allegan, Mich.-based private labeler says Sept. 18. The patent litigation, originally filed in April in the U.S. District Court for the District of New Jersey, claimed McNeil's patent for Monistat 1 - which generates about $80 million in annual retail sales for the firm - had been infringed. The lawsuit initiated a 30-month stay period, now over, on FDA's approval of the generic product under the Hatch-Waxman Act (1"The Tan Sheet" April 28, 2008, In Brief). Perrigo President and CEO Joseph Papa say generic Monistat is "an important new product in the feminine hygiene category to our retail and wholesale customers," and the firm says it expects to launch it upon regulatory approval

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