The company believes that it is the first to file an ANDA with a Paragraph IV certification against Monistat 1. Perrigo also notified Johnson & Johnson, the new drug application holder for Monistat 1 Combination Pack, and McNeil-PPC, the listed patent owner, of its filing.
On April 18, 2008, McNeil filed suit alleging patent infringement in the US District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product.
Monistat 1 Combination Pack (miconazole nitrate vaginal cream, 2% and suppository, 1.2g) is an antifungal medication indicated for the treatment of vaginal yeast infections.