Perrigo has launched of the testosterone topical solution 30 mg/1.5 mL, the generic equivalent to Eli Lilly and Company’s Axiron topical solution, 30 mg/1.5 mL. The product is intended for men with hypogonadism, a condition in which men do not produce enough of the male hormone due to injury or disease that results in symptoms such as fertility problems. Axiron earned about $248 million in annual market sales for the 12 months ending April 2017.
Testosterone replacement therapies have gathered a lot of attention in recent years, first with aggressive marketing campaigns by their manufacturers luring men to try the products for relief of symptoms of so-called Low T, such as low libido, muscle loss, weight gain and mood swings. But more recently, the products have garnered attention because they have become the target of thousands of lawsuits.
Men are suing the drug companies over claims that they were not adequately warned about testosterone side effects, including heart attacks, strokes, blood clots and death. Studies had linked the use of testosterone therapy to cardiac events but the drug companies failed to pass this information along to prescribing doctors or patients in their direct-to-consumer advertising, lawsuits allege.
The first bellwether trials among the thousands filed in the multidistrict litigation in the U.S. District Court for the Northern District of Illinois have targeted AbbVie Inc. and its testosterone treatment AndroGel. This month, two cases waged against Eli Lilly and Co. were selected to serve as bellwethers.
Other testosterone manufacturers named in the testosterone MDL include Endo Pharmaceuticals, Actavis Inc., Auxilium Pharmaceuticals Inc., Pfizer and Pharmacia.