GlaxoSmithKline files suit against Watson over generic JALYN

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market  dutasteride and tamsulosin hydrochloride capsules. Watson's dutasteride and tamsulosin hydrochloride capsules are a generic version of GlaxoSmithKline's JALYN™. JALYN™ capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

GlaxoSmithKline filed suit against Watson on July 21, 2011 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its 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 December 30, 2013, or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.  

For the twelve months ending May 31, 2011, JALYN™ capsules had total U.S. sales of over $30 million according to IMS Health data.