Watson Pharmaceuticals, Inc., a global, integrated specialty pharmaceutical company, has confirmed that Actavis, Inc., has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market bortezomib.
Actavis' ANDA product is a generic version of Millennium Pharmaceuticals' Velcade (bortezomib), which is a proteasome inhibitor, for intravenous or subcutaneous administration, approved for the treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
Watson had acquired Actavis in October this year.
Millennium filed suit against Actavis on December 21, 2012, in the US District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of certain US patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ending October 31, 2012, Velcade had total US sales of approximately $740 million according to IMS Health data.