Watson confirms Velcade patent challenge; Mylan debuts generic Nordette

US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) on Friday confirmed that its subsidiary Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market bortezomib, 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.

Millennium, the USA-based oncology subsidiary of Japan’s largest drugmaker Takeda (TSE: 4502), 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 law suit 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 U.S. sales of around $740 million according to IMS Health data quoted by Watson.