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 rasagiline mesylate 0.5 and 1.0 mg tablets. Watson's rasagiline mesylate tablets are generic versions of Teva Neuroscience, Inc.'s Azilect® Tablets, which are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.
Teva Neuroscience, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. filed suit against Watson on October 1, 2010 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 5,453,446. Teva'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 16, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the 0.5 and 1.0 mg generic versions of Azilect® and, should its ANDA be approved, may be entitled to 180 days of shared generic market exclusivity with other ANDA applicants that filed on the same day as Watson. For the twelve months ending June 30, 2010, Azilect® had total U.S. sales of approximately $108 million according to IMS Health data.
SOURCE Watson Pharmaceuticals, Inc.