Mayne Pharma Wins Longer IMVEXXY Runway With 2032 Generic Deal

Sun Pharma Litigation Settled With 2032 Entry Date

Mayne Pharma Group Limited (ASX:MYX) has secured a potential expiry runway for one of its key women’s health products, settling US patent litigation with Sun Pharmaceutical Industries over IMVEXXY. Under the agreement, Sun Pharma’s generic could enter the US market on 21 October 2032, or earlier in certain circumstances, subject to court approval of the settlement.

The agreement resolves Paragraph IV proceedings launched in July 2024 over patents listed in the US Food and Drug Administration’s Orange Book. It does not involve any financial payment or upfront monetary consideration between the parties, making the commercial value of the outcome dependent primarily on the agreed timing and the continued performance of IMVEXXY.

IMVEXXY Remains a Growing Women’s Health Asset

IMVEXXY is a locally administered estradiol vaginal insert used to treat moderate to severe dyspareunia associated with menopause. In the 12 months to 30 June 2026, prescriptions increased 6% from the previous corresponding period, while net sales rose 8% to US$29.3 million.

That growth gives the patent timetable practical significance, although the filing does not quantify how much revenue the settlement may preserve or forecast the product’s future sales. Mayne Pharma said it would continue managing and defending its intellectual property portfolio while pursuing access, adherence and prescriber-engagement initiatives for the product. CEO Aaron Gray described the resolution as an important step in protecting IMVEXXY’s value and planning its longer-term contribution to the menopause portfolio, in comments released by Mayne Pharma (ASX:MYX).

One IMVEXXY Patent Dispute Still Open

The settlement reduces the number of active Paragraph IV disputes involving IMVEXXY, but it does not close the product’s entire patent litigation front. Mayne Pharma said one further matter remains ongoing, without identifying the counterparty or disclosing its current status.

The immediate milestones are therefore court approval of the Sun Pharma settlement and clarification of the circumstances that could permit earlier generic entry. The February 2034 expiry of the last IMVEXXY patent cited by Mayne Pharma also leaves a gap between the agreed 2032 entry date and the end of the stated patent life, but the filing does not explain how the settlement interacts with each individual patent.