Actavis seeks approval for generic testosterone-replacement drug

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

In response to the filing, Lilly and another company, Acrux, filed a patent-infringement suit against Actavis in the U.S. District Court for the Southern District of Indiana. The lawsuit puts an automatic stay of FDA approval on Actavis' product for 30 months or until the companies settle the case. Actavis said it was the first company to file for FDA approval and expects to have 180 days in which to compete directly against Lilly's product upon approval.

Axiron had sales of about $257 million during the 12-month period that ended in September, according to IMS Health.