Watson Pharma confirms challenge of GlaxoSmithKline Jalyn patent

US generic drugs firm Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market dutasteride and tamsulosin hydrochloride capsules, a generic version of UK pharma giant GlaxoSmithKline's (LSE: GSK) Jalyn, which is are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

GSK filed suit against Watson on July 21 in the US 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. GSK's law suit 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 12 months ending May 31, 2011, Jalyn capsules had total US sales of over $30 million according to IMS Health data quoted by Watson.