Perrigo Company Confirms Patent Challenge for Clobetasol Propionate Emulsion Foam 12:03p ET July 14, 2010 (PR NewsWire) Perrigo Company (Nasdaq: PRGO; TASE) announced its filing with the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05% and notified Stiefel Research Australia Pty. Ltd., the listed patent owner. Perrigo believes it is first-to-file on this product.
On July 12, 2010, 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.
The product is the AB-rated equivalent to Stiefel Laboratories' Olux(R) -E Foam, 0.05%, a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand were up 18% year over year at approximately $41.5 million, according to Wolters Kluwer data for the twelve months ending May 2010.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders."