Indianapolis-based Eli Lilly and Co. and Acrux DDS Pty Ltd. have filed a lawsuit against Lupin Pharmaceuticals Inc. for alleged infringement of patents that cover the testosterone treatment Axiron.
West Melbourne, Australia-based Acrux owns the patent and licenses it exclusively to Lilly, according to the complaint.
Baltimore-based Lupin has filed an abbreviated new drug application with the U.S. Food and Drug Administration for approval to market a generic version of Lilly’s drug, in violation of its patent protections, Lilly and Acrux said in their lawsuit.
Axiron is a topical drug used to treat what’s commonly referred to as “low T,” or testosterone deficiency, in males.
Global sales for Axiron were $170.5 million in 2014, down from $179 million in 2013, Acrux reported. The product's share of the topical testosterone market was 13.7 percent at the end of 2014.
“Lilly and Acrux are committed to asserting their intellectual property rights for Axiron,” the companies said in a written statement.
They claim the drug and its method for underarm application is protected against generic competition until at least 2026, according to the statement.
Earlier this year, the U.S. Food & Drug Administration ordered makers of testosterone drugs to change the products’ labels to clarify that they are approved for only certain disorders, not to help men deal with aging.