(RTTNews) - Mayne Pharma Group Limited (MYX.AX) has reached settlement with Sun Pharmaceutical Industries Ltd. (SUNPHARMA.NS), resolving the Paragraph 1V patent litigation concerning IMVEXXY (estradiol vaginal inserts) and its U.S. FDA Orange Book-listed patents.
Under the settlement, Sun Pharma has agreed to an earliest generic market entry date of October 21, 2032, or earlier under certain limited circumstances, subject to court approval.
No financial payments were made between the parties as part of the settlement.
Mayne Pharma said the settlement reinforces the validity and enforceability of its IMVEXXY patent portfolio, with the last-expiring patent extending to February 2034.
Mayne said that IMVEXXY remains a contributor to its Women's Health business. For the 12 months ended June 30, 2026, total prescriptions increased 6%, while net sales rose 8% to $29.3 million.
The company noted that one additional Paragraph IV litigation matter involving IMVEXXY remains ongoing.
MYX.AX is trading up 2.47% at AUD 2.90 on the Australian Stock Exchange.
Sun Pharma shares are down 1.50% at INR 1,837.10 on the National Stock Exchange.