Teva Pharmaceuticals Ltd., announced it has launched CII, a generic version of the testosterone replacement therapy Axiron, a topical solution of the prescription medication used to treat adult males with low levels of testosterone due to injury, disease or defect.
“We are pleased with the result in the district court, which has helped Teva add yet another product to our industry-leading generic portfolio, providing savings to our customers and to patients,” said Andy Boyer, Teva’s President and CEO, Global Generic Medicines, North America.
Axiron is manufactured by Eli Lilly and Co., and has annual sales of about $247 million in the U.S. In July, pharmaceutical company Perrigo announced it had launched a generic Axiron in a race to capture some of the brand-name drug’s revenue.
Sales of brand-name Axiron will likely take a hit from its new generic competition, but also because it is named in more than 6,000 lawsuits consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Illinois. The MDL accuses testosterone manufacturers, including Lilly and AbbVie, makers of top-seller AndroGel, of failing to warn doctors and patients of testosterone side effects, such as an increased risk of heart attack, stroke, blood clots and death. The cases also accuse testosterone makers of aggressively marketing the male hormone supplements in an effort to increase sales.
Two cases naming Lily’s Axiron have been selected to serve as bellwethers in the MDL. Two previous bellwethers, both targeting Abbie’s AndroGel, have resulted in $140 million and $150 million verdicts.