Patent Law Practice Center

Hatch-Waxman: Eli Lilly Sues Actavis after ANDA Filed on Axiron®

Actavis PLC (NYSE: ACT) recently filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Topical Solution, 30mg/1.5mL.  Actavis’ ANDA product is a generic version of Eli Lilly and Company’s 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 Company and Acrux DDS Pty Ltd. filed suit against Actavis on November 12, 2013, 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 of certain of its U.S. 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.

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