ALLEGAN, Mich., May 2, 2011 /PRNewswire/ — Perrigo Company
PRGO; TASE) today announced that it has received final approval
from the U.S. Food and Drug Administration for its abbreviated new
drug application for over-the-counter (OTC) 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 2011, 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.
Perrigo’s Chairman and CEO Joseph C. Papa concluded, “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 is a leading global healthcare supplier that
develops, manufactures and distributes OTC and generic prescription
(Rx) pharmaceuticals, infant formulas, nutritional products, active
pharmaceutical ingredients (API) 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. Visit Perrigo on
the Internet (http://www.perrigo.com).
Note: Certain statements in this press relea