Watson Confirms AVODART Patent Challenge

Watson Pharmaceuticals, Inc. WPI today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Dutasteride Capsules, 0.5 mg. Watson's Dutasteride Capsules product is a generic version of GlaxoSmithKline's AVODART, which is indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate. GlaxoSmithKline LLC filed suit against Watson on June 17, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its Dutasteride Capsules product prior to the expiration of U.S. Patent No. 5,565,467. GlaxoSmithKline's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until November 17, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.