Monistat 1 patent suit
This article was originally published in The Tan Sheet
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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Perrigo's abbreviated new drug application for OTC miconazole nitrate vaginal cream, 2 percent, and suppository, 1.2 grams, has been challenged by McNeil, the owner of the Monistat 1 Combination Pack patent, the Allegan, Mich.-based private labeler announces April 21. McNeil filed the suit alleging patent infringement April 18 in the U.S. District Court for the District of New Jersey. The suit initiates the patent process under the Hatch-Waxman Act, placing a 30-month stay on FDA's approval for generic Monistat 1. The combo pack of the antifungal miconazole nitrate vaginal cream and suppository for treating yeast infections had approximately $50 million in sales for April 2007-March 2008, according to Information Resources, Inc., data cited by Perrigo...
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