Watson seeks FDA approval to market Epiduo Gel for severe acne

Jul 30 2012

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Epiduo® (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%. Watson's ANDA product is a generic version of Galderma Laboratories, L.P.  Epiduo® Gel is a topical ointment prescription drug that combines a retinoid (adapalene) and an antimicrobial (benzoyl peroxide) for the treatment of acne vulgaris (severe acne) in people who are at least 12 years old.

Galderma Laboratories, L.P.  filed suit against Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc., on July 27, 2012 in the United States District Court for the Northern District of Texas Dallas Division seeking to prevent Watson from commercializing its ANDA product prior to the expiration of certain U.S. patents.  The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

For the twelve months ending March 31, 2012, Epiduo® Gel had total U.S. sales of approximately $199 million according to IMS Health data.