Mayne Pharma, Sun Pharma Settle IMVEXXY Patent Case; Generic Entry Set for October 2032

Mayne Pharma Group Ltd. (MYX.AX) said Sun Pharmaceutical Industries Ltd. (SUNPHARMA.NS) has agreed to settle U.S. Paragraph IV patent litigation over IMVEXXY, with Sun Pharma accepting an earliest generic market entry date of October 21, 2032, subject to court approval. No financial payment or upfront consideration is included in the settlement. The agreement resolves litigation Mayne filed in July 2024 alleging infringement of 20 Orange Book-listed patents after Sun Pharma submitted an ANDA with a Paragraph IV certification, triggering a 30-month Hatch-Waxman stay on potential FDA approval. For the 12 months ended June 30, 2026, IMVEXXY prescriptions rose 6% and net sales climbed 8% to $29.3 million. Mayne said one additional Paragraph IV matter involving IMVEXXY remains ongoing. MYX.AX closed Wednesday at A$2.92, up 3.18%.