Actavis, Inc., a global, integrated specialty pharmaceutical company, has confirmed the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Testosterone gel 10mg/0.5g. Actavis' ANDA product is a generic version of Endo Pharmaceuticals' Fortesta, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Endo and Strakan International S.a r.l. filed suit against Actavis on February 28, 2013, in the US District Court for the Eastern District of Texas Marshall Division 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.
Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Fortesta and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the 12 months ending December 31, 2012, Fortesta had total US sales of approximately $50 million according to IMS Health data.