Actavis, Inc. today confirmed that it has filed with the U.S. Food and Drug Administration (FDA) an amendment to its Abbreviated New Drug Application (ANDA) for Rivastigmine Transdermal System to include the 13.3 mg per 24 hours dosage strength. Actavis' ANDA product is a generic version of Novartis' Exelon Patch, which 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 March 7, 2013 in the United States District Court for the District of Delaware seeking to prevent Actavis from commercializing its 13.3 mg/ 24 hr strength product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's 13.3 mg/ 24 hr strength ANDA product for up to 30 months from the date that Novartis received notice of Actavis' ANDA amendment filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Actavis previously filed an ANDA with the FDA seeking approval to market Rivastigmine Transdermal System patch 4.6 mg/24 hr and 9.5 mg/24 hr, and was subsequently sued by Novartis in November 2011.
That application is subject to a separate 30-month stay.
Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of each strength of Exelon Patch and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve months ending January 31, 2013, Exelon had total U.S. sales of approximately $521 million according to IMS Health data.