Australian company Acrux and its partner US-based Eli Lilly have filed a lawsuit against Lupin Pharmaceuticals alleging infringement of US patents covering testosterone therapy, AXIRON.
The patents are owned by Melbourne-based Acrux, and exclusively licensed to Lilly.
Acrux was founded in the late 1990s by a group of research pharmacists at the Victorian College of Pharmacy, now part of Monash University, who discovered the drug delivery technology that would give life to AXIRON.
AXIRON is available in the US, and in Australia via the PBS, for the treatment of confirmed androgen deficiency in males.
The lawsuit filed by Acrux and Lilly is in response to a notice sent by Lupin regarding its filing with the FDA of an Abbreviated New Drug Application for a Testosterone Metered Dose Transdermal Solution.
According to the two companies, Lupin is alleging that several patents set to expire between 2026 and 2030 are invalid or unenforceable.
"Lilly and Acrux are committed to asserting their intellectual property rights for AXIRON," said the companies. "As with prior notices, the conduct of the lawsuit will not have a material impact on its operating expenditure."