Perrigo Company (Perrigo) has filed an Abbreviated New Drug Application (ANDA) 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 $52m annually.
Reportedly, Perrigo has filed its ANDA for Minoxidil topical aerosol foam, 5%, containing a paragraph IV certification with the FDA and notified Johnson & Johnson, the New Drug Application holder for Rogaine Foam, and Stiefel Research Australia (SRA) , the listed patent owner, of its filing.
On October 9, 2009, SRA has filed a suit alleging patent infringement in the US District Court for the District of Delaware to prevent Perrigo from proceeding with the commercialisation of this product. This action formally initiates the process under the Hatch-Waxman Act.
Joseph Papa, chairman and CEO at Perrigo, said: “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 $10billion compared to the national brand.”