Mayne Pharma, Sun Pharma Settle IMVEXXY Patent Case, Generic Entry Set For 2032
(RTTNews) - Mayne Pharma Group Ltd. (MYX.AX) announced that Sun Pharmaceutical Industries Ltd. (SUNPHARMA.NS) has agreed to settle U.S. Paragraph IV patent litigation concerning IMVEXXY and its associated FDA Orange Book-listed patents.
Under the settlement terms, Sun Pharma has agreed to an earliest generic market entry date of October 21, 2032, or earlier under certain circumstances, subject to court approval. The settlement includes no financial payment or upfront monetary consideration.
IMVEXXY is a locally administered estradiol vaginal insert used in the treatment of moderate to severe dyspareunia due to menopause.
The settlement resolves patent litigation brought by Mayne Pharma against Sun Pharma in July 2024, alleging infringement of 20 Orange Book-listed patents related to IMVEXXY.
The lawsuit followed Sun Pharma's ANDA submission to the FDA, which included a Paragraph IV certification challenging Mayne Pharma's patents. Notably, the action triggered a 30-month stay under the Hatch-Waxman Act on any potential FDA approval of Sun Pharma's ANDA.
"Resolving the Paragraph IV litigation with Sun Pharma is an important step in protecting the value of IMVEXXY", said Aaron Gray, CEO of Mayne Pharma.
For the 12 months ended June 30, 2026, IMVEXXY 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 has traded between A$2.04 and A$6.50 over the last year.
MYX.AX closed Wednesday's trade at A$2.92, up 3.18%.
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