Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for over-the-counter Minoxidil Foam, a generic version of Men’s Rogaine Foam.
Perrigo had been sued for patent infringement by Stiefel Research Australia Pty. Ltd., a GSK Company, when it submitted its Paragraph IV ANDA. Under the terms of the settlement reached between the parties in February, Perrigo can launch the generic version of Men’s Rogaine Foam in the U.S. on March 1, 2012, or earlier, under certain circumstances. The product will be entitled to 180 days of generic exclusivity upon launch.
Rogaine (Minoxidil) Foam is used to regrow hair on the top of the scalp, and has annual sales of approximately $60 million, as measured by Information Resources Inc.
Said Perrigo chairman and CEO Joseph C. Papa: “This is another example of Perrigo’s commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers.”
Perrigo Company develops, manufactures and distributes over the counter and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients and pharmaceutical and medical diagnostic products. The company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
More at www.perrigo.com.