By Digifin Pty Ltd · About this coverage
Key Points
- Settlement with Teva Pharmaceuticals USA resolves Paragraph IV litigation over IMVEXXY patents
- Agreed generic entry date of 2 September 2032, or earlier under certain circumstances
- No financial payment or upfront monetary consideration between the parties
- IMVEXXY net sales up 8% to US$29.3 million in the 12 months to 30 June 2026
- Settlement terms subject to court approval
About Mayne Pharma (ASX:MYX)
Mayne Pharma Group Limited is an ASX-listed specialty pharmaceutical company headquartered in Adelaide. It commercialises dermatology and women's health medicines, primarily in the United States, and operates a direct-to-patient prescription distribution platform through its licensed pharmacy, Adelaide Apothecary. The company also provides contract development and manufacturing services to clients worldwide.
Mayne Pharma (ASX:MYX) has settled US patent litigation with Teva Pharmaceuticals USA over IMVEXXY, resolving its last outstanding Paragraph IV case on the product and setting a date for generic entry.
The settlement resolves litigation commenced in April 2020 over IMVEXXY (estradiol vaginal inserts) and its FDA Orange Book-listed patents, brought by Mayne Pharma and TherapeuticsMD. It provides an agreed pathway for potential future entry of a Teva Pharmaceuticals USA generic product on 2 September 2032, or earlier under certain circumstances. The settlement does not include any financial payment or upfront monetary consideration between the parties. Chief Executive Aaron Gray says it follows a settlement with Sun Pharma announced on 30 September, and the company now has no further ongoing Paragraph IV litigation matters for IMVEXXY. The last expiring IMVEXXY patent runs to February 2034. 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.
The settlement terms are subject to court approval, and the release does not describe the circumstances that could allow earlier generic entry.
Source: Mayne Pharma Group Limited (ASX:MYX), 16 October 2026. Summary content supplied by Digifin Pty Ltd.
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