Patent lawsuit over Perrigo's Monistat-1 dismissed

ALLEGAN, Mich. Perrigo on Thursday announced that the Hatch-Waxman litigation relating to Miconazole Nitrate Vaginal Cream and Suppository between Johnson & Johnson and Perrigo has been dismissed. Accordingly, Perrigo plans to launch a store brand version of the Monistat-1 Combination Pack following Food and Drug Administration approval, the company reported.

“This is another example of Perrigo’s commitment to continue bringing new store brand products to the market, stated Perrigo president and chief executive officer Joe Papa. “The one-day Miconazole cream and suppository introduction to the store brand market provides an important new product in the feminine hygiene category to our retail and wholesale customers while providing significant savings for the consumer. Perrigo is working every day to make quality healthcare more affordable.”

Earlier this year, Perrigo had been sued by Johnson & Johnson’s McNeil unit for infringement of a patent related to Perrigo’s filing of an ANDA for a generic to Monistat-1 Combination Pack in the United States District Court for the District of New Jersey.

Monistat-1 has annual retail sales of approximately $80 million dollars, Perrigo reported. The dismissal of the lawsuit ends the 30 month Hatch-Waxman stay period, which was originally set to expire in September 2010. Perrigo expects its pending launch to have 180 day first-to-file exclusivity.