McNeil challenges Perrigo’s Monistat 1 ANDA
This article was originally published in The Tan Sheet
Executive Summary
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...