Watson Confirms JALYN(TM) Patent Challenge
24-Jul-2011
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PARSIPPANY, NJ - Watson Pharmaceuticals Inc. confirmed in a press release that its subsidiary, Watson Laboratories Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the US 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(TM). JALYN(TM) 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 US 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(TM) capsules had total US sales of over $30 million according to IMS Health data.
Watson Pharmaceuticals Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.