MYX settles US patent litigation re Imvexxy with Sun Pharma
ASX Announcement
MAYNE PHARMA SETTLES US PATENT LITIGATION
RELATING TO IMVEXXY®
WITH SUN PHARMA
Key Points:
• Settlement reached with Sun Pharma resolving Paragraph IV litigation concerning IMVEXXY® FDA
Orange Book patents
• Settlement includes an agreed market entry date of generic IMVEXXY® of 21 October 2032
• The settlement highlights the validity and enforceability of the IMVEXXY® patent portfolio
• Mayne Pharma continues to support IMVEXXY® and defence of its IP portfolio with the last expiring
patent in February 2034
30 September 2026, Adelaide, Australia: Mayne Pharma Group Limited (Mayne Pharma or the
Company) (ASX: MYX), today announces that Sun Pharmaceutical Industries Ltd (Sun Pharma) has
agreed to resolve the US Paragraph IV litigation relating to IMVEXXY® (estradiol vaginal inserts) and
the associated FDA Orange Book-listed patents, brought by Mayne Pharma and TherapeuticsMD.
The settlement resolves ongoing patent litigation with Sun Pharma (commenced in July 2024)
and provides an agreed pathway for potential future entry of a Sun Pharma generic product on
21 October 2032, or earlier under certain circumstances, subject to court approval of the
settlement terms. The settlement does not include any financial payment or upfront monetary
consideration between the parties.
Mr Aaron Gray, CEO of Mayne Pharma said “Resolving the Paragraph IV litigation with Sun Pharma
is an important stepinprotectingthevalueof IMVEXXY®.Theagreed pathway strengthens ourlonger
term planning for IMVEXXY® within our menopause portfolio as part of our overall Women’s Health
business. We will continue to actively manage and defend our IP estate and execute on access and
patient support initiatives to maximise the product’s patent life and long-term contribution.”
IMVEXXY® is a locally administered estradiol vaginal insert used in the treatment of moderate to
severe dyspareunia due to menopause. The product sits within Mayne Pharma’s Women’s Health
franchise and is supported by ongoing commercial execution initiatives focused on access,
adherence and prescriber engagement. In the 12 months to 30 June 2026, IMVEXXY® total
prescriptions grew 6% over the prior corresponding period and net sales were up 8% to US$29.3
million.
After the settlement announced today, the Company has one further ongoing Paragraph IV
litigation matter for IMVEXXY®.
Click here to view the announcement on Investor Hub.
- ENDS -
ASX Announcement
Page 2
For further information contact:
Dr Tom Duthy
Investor Relations
+61 402 493 727
ir@maynepharma.com
Authorised for release to the ASX by the Board Chair.
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercialising
novel pharmaceuticals, offering patients better, safe and more accessible medicines. Mayne
Pharma is a leader in dermatology and women’s health in the United States and also provides
contract development and manufacturing services to clients worldwide. Mayne Pharma has a 40-
year track record of innovation and success in developing new oral drug delivery systems. These
technologies have been successfully commercialised in numerous products that continue to be
marketed around theworld. Tolearn more about MaynePharma, pleasevisit maynepharma.com.
IMVEXXY®
is a trademark of a third party.
About Paragraph IV litigation
In the United States, generic manufacturers can seek approval to market a generic version of a
branded medicine by filing an abbreviated new drug application (ANDA) with the U.S. Food and
Drug Administration (FDA) under the Hatch-Waxman framework. A Paragraph IV certification
alleges that one or more Orange Book-listed patents for the branded product are invalid,
unenforceable or not infringed, which may lead to patent litigation. If the brand company
commences patent infringement proceedings within the statutory timeframe (commonly referred
to as 45 days), this can trigger an automatic stay of FDA final approval of the ANDA for up to 30
months (subject to applicable circumstances) or until the dispute is resolved, including via
settlement.
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