Mayne Pharma Group (ASX:MYX) settled Paragraph IV patent litigation with Sun Pharmaceutical Industries concerning Imvexxy, an estradiol vaginal insert used to treat moderate to severe menopause-related dyspareunia, including disputes over patents listed for the drug in the US Food and Drug Administration's Orange Book, according to a Wednesday Australian bourse filing.
Sun Pharma's generic version of the treatment may enter the US market on Oct. 21, 2032, or earlier under certain circumstances, subject to court approval, with no financial payment or upfront consideration between the parties, the filing said.
The company said the settlement reinforces the validity and enforceability of its patent portfolio covering the product, with the final patent set to expire in February 2034, the filing added.
The specialty pharmaceutical company's shares gained about 1% in recent Wednesday trade.