Perrigo Company today announced that it has filed an ANDA for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream, 2% and Suppository, 1.2g, a generic version of Monistat(R) 1 Combination Pack. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against Monistat 1.
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, and had sales of approximately $50 million for the 12 months ended March 2008.
Perrigo filed its ANDA for Miconazole Nitrate Vaginal Cream, 2% and Suppository 1.2g containing a Paragraph IV Certification with the USFDA and notified J & J, the NDA holder for Monistat 1 Combination Pack, and McNeil-PPC, Inc., the listed patent owner, of its filing. On April 18, 2008, McNeil filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act and will lead to 30 months stay for the approval of ANDA for this product.
There are two patents listed in OB for this product i.e. US5514698 and US6153635 expiring in March 2014 and Nov. 2018 respectively. The patents cover the composition, method of treatment and kit comprising miconazole nitrate as active ingredient.
No comments:
Post a Comment