Perrigo Files ANDA for OTC Minoxidil Topical Aerosol Foam

Perrigo Company has filed an Abbreviated New Drug Application (ANDA) for 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, according to Perrigo.

Perrigo, based in Allegan, MI, 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 Oct. 9, 2009, Stiefel Research Australia Pty. Ltd. filed suit alleging patent infringement in the U.S. 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.

“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,” said Perrigo’s chairman and CEO Joseph C. Papa.