Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market its darifenacin hydrobromide extended-release 7.5 mg and 15 mg product prior to the expiration of a patent owned by Novartis AG. Watson's darifenacin hydrobromide extended-release product is the generic version of Novartis AG's Enablex which is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Novartis AG filed suit against Watson on April 24, 2009 in the US District Court for the District of Delaware seeking to prevent Watson from commercializing its products prior to expiration of US patent number 6,106,864. Novartis AG's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.
For the twelve-months ended December 31, 2008, Enablex had total US sales of approximately $220 million, according to IMS Health data.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.