Actavis Confirms Generic Axiron Patent Challenge

(RTTNews) - Actavis plc (ACT) confirmed Thursday that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Testosterone Topical Solution, 30mg/1.5mL.

Actavis' ANDA product is a generic version of Eli Lilly and Co.'s (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 Ltd. filed suit against Actavis on November 12 in the U.S. District Court for the Southern District of Indiana seeking to prevent Actavis from commercializing its ANDA product prior to the expiration certain of U.S. patents. The lawsuit resulted 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 September 30, 2013, Axiron had total U.S. sales of about $257 million, according to IMS Health data.