Perrigo Confirms Filing for Generic Version of Men's Rogaine(R) Foam

Perrigo Company today announced that it has filed an Abbreviated New Drug Application for over-the-counter (OTC) Minoxidil topical aerosol foam, 5%, a generic form of Men's Rogaine(®) Foam.

Men's Rogaine(®) (Minoxidil) topical aerosol foam, 5%, is a topical hair re-growth treatment indicated for the re-growth of hair on top of the scalp, and has estimated sales at retail of approximately $52 million annually.

Perrigo filed its ANDA for Minoxidil topical aerosol foam, 5%, containing a paragraph IV certification with the U.S. Food & Drug Administration and notified Johnson & Johnson, the New Drug Application holder for Rogaine(®) Foam, and Stiefel Research Australia Pty. Ltd., the listed patent owner, of its filing. On October 9, 2009, Stiefel Research Australia Pty. Ltd. filed suit alleging patent infringement in the United States District Court for the District of Delaware to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of how our ongoing focus on innovation and consistently bringing new products to market saves consumers money. Over the past 15 years Perrigo products have saved consumers over an estimated $10 billion compared to the national brand."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic 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 and logistics operations are the United
States, Israel, Mexico and the United Kingdom.

read more» Read more...