Actavis confirms challenge of Lilly’s Axiron patent

US generics major Actavis (NYSE: ACT) confirms that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market testosterone topical solution, 30mg/1.5mL.

Actavis' ANDA product is a generic version of pharma major Eli Lilly’s (NYSE: LLY) Axiron, which is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Eli Lilly and Acrux DDS Pty filed suit against Actavis on November 12, 2013, in the US District Court for the Southern District of Indiana seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of 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.