The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the Hatch-Waxman litigation relating to Miconazole Nitrate Vaginal Cream and Suppository between Johnson & Johnson and Perrigo has been dismissed. 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. Following FDA approval, Perrigo will begin marketing its product under store brand and value brand labels to its customers.
Perrigo's President and CEO Joseph C. Papa stated, "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. Perrigo is working every day to make quality healthcare more affordable."
Monistat® -1 has annual retail sales of approximately $80 million dollars. This OTC product is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation due to a vaginal yeast infection. 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.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet ( http://www.perrigo.com/ ).
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 28, 2008, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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