Actavis, Inc.,a global, integrated specialty pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) recently seeking approval to market Testosterone gel, 1.62 per cent. Actavis' ANDA product is a generic version of AbbVie Inc.'s AndroGel 1.62 per cent, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Unimed Pharmaceuticals, LLC, which is a wholly-owned subsidiary of AbbVie Inc., and Besins Healthcare Inc. filed suit against Actavis on March 29, 2013, in the US District Court for the District of Delaware seeking to prevent Actavis from commercialising its ANDA product prior to the expiration of US Patent No. 6,503,894. 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 January 31, 2013, AndroGel 1.62 per cent had total US sales of approximately $690 million according to IMS Health data.
Actavis, Inc. is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products.