Perrigo Company has announced that it has received final approval from the FDA for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack. Perrigo expects to begin shipping immediately.
Monistat@ -1 has annual retail sales of approximately $90 million dollars. This OTC product is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation they cause. Perrigo was the first to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson was previously dismissed. Perrigo’s approval includes 180 days of generic marketing exclusivity.
Perrigo’s Chairman and CEO Joseph C. Papa concluded, “This is another example of Perrigo’s commitment to innovation by challenging brand patents and bringing new products to market. These innovations help save OTC healthcare consumers more than an estimated $1 billion annually.”