Watson Pharmaceuticals, Inc. (WPI), a leading integrated global pharmaceutical company, said that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market rivastigmine transdermal system patches, 4.6 mg/24 hr and 9.5 mg/24 hr.
Watson's rivastigmine transdermal system patch is a generic version of Novartis' Exelon Patch. Exelon is a prescription medicine used to treat people with mild to moderate dementia associated with Alzheimer's or Parkinson's disease.
Novartis filed suit against Watson on November 9, 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 Nos. 5,602,176; 6,316,023 and 6,335,031. The lawsuit 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 from the date that Novartis received notice of Watson's ANDA filing 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 generic version of Exelon Patch and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
According to IMS Health data, the twelve months ending September 30, 2011, Exelon had total US sales of approximately $424 million.