Mayne Pharma Group (ASX:MYX) reached a settlement with Teva Pharmaceuticals USA to resolve litigation related to Imvexxy and the associated US Food and Drug Administration Orange Book-listed patents, according to a Friday filing with the Australian bourse.
The US Paragraph IV litigation was brought by Mayne Pharma and TherapeuticsMD.
The settlement provides a pathway for the potential entry of a Teva Pharmaceuticals generic product on Sept. 2, 2032, or earlier under certain circumstances, subject to court approval. It does not include any financial payment between the parties.
Imvexxy is a vaginal insert used in the treatment of moderate to severe dyspareunia, or pain associated with sexual intercourse, due to menopause.
Mayne Pharma shares gained 3% in recent Friday trade.