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news.The Perrigo Company, a global healthcare supplier, has announced that the Hatch-Waxman litigation relating to Miconazole nitrate vaginal cream and suppository between Johnson & Johnson and Perrigo has been dismissed.
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The dismissal of the lawsuit ends the 30-month Hatch-Waxman stay period, which was originally set to expire in September 2010. Upon receiving final regulatory approval, Perrigo expects to launch this product. The company expects this launch to have 180-day first-to-file exclusivity.
Earlier in 2008, Perrigo had been sued by Johnson & Johnson’s McNeil unit for infringement of a patent related to Perrigo’s filing of an abbreviated new drug application for a generic to Monistat-1 combination pack in the US District Court of New Jersey. Following FDA approval, Perrigo will begin marketing its product under store brand and value brand labels to its customers.
Joseph Papa Perrigo’s president and CEO, said: “This is another example of Perrigo’s commitment to continue bringing new store brand products to the market. 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.”