Teva settlement sets 2 September 2032 generic entry date for IMVEXXY
Mayne Pharma Group Limited (ASX: MYX) has reached an IMVEXXY patent settlement, with Teva Pharmaceuticals USA Inc. agreeing to resolve the US Paragraph IV litigation over IMVEXXY® (estradiol vaginal inserts) and the associated FDA Orange Book-listed patents. The Mayne Pharma Teva settlement was announced on 16 October 2026.
The settlement provides an agreed pathway for potential future entry of a Teva Pharmaceuticals USA generic product on 2 September 2032, or earlier under certain circumstances, subject to court approval of the settlement terms.
The litigation was brought by Mayne Pharma and TherapeuticsMD and commenced in April 2020. The settlement does not include any financial payment or upfront monetary consideration between the parties.
Key points from the announcement:
- Settlement with Teva Pharmaceuticals USA Inc.
- Agreed generic entry date of 2 September 2032, or earlier under certain circumstances
- No financial payment or upfront monetary consideration
- Last expiring patent in February 2034
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All Paragraph IV litigation for IMVEXXY now resolved
Second settlement in weeks
The Teva agreement follows the Sun Pharma settlement announced on 30 September. The terms of that earlier settlement are not disclosed in this announcement.
According to the company, after the settlement announced today, Mayne Pharma has no further ongoing Paragraph IV litigation matters for IMVEXXY®.
Aaron Gray, CEO, Mayne Pharma
“Together, these settlements give us clarity on the generic entry landscape and remove the cost and uncertainty of ongoing litigation. This provides a firm foundation for our longer-term planning for IMVEXXY® within our menopause portfolio and broader Women’s Health business…”
What Paragraph IV litigation means
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 Food and Drug Administration (FDA) under the Hatch-Waxman framework. A Paragraph IV certification alleges that one or more Orange Book-listed patents are invalid, unenforceable or not infringed.
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.
The typical sequence runs as follows:
- ANDA filed
- Paragraph IV certification
- Suit commenced within 45 days
- Automatic stay of up to 30 months
- Resolution, including via settlement
For investors, a settlement replaces open-ended litigation with a defined date, in this case 2 September 2032.
IMVEXXY performance and investment case
IMVEXXY® is a locally administered estradiol vaginal insert used in the treatment of moderate to severe dyspareunia due to menopause. It sits within Mayne Pharma’s Women’s Health franchise.
The company reported the following for the 12 months to 30 June 2026:
| Metric | 12 months to 30 June 2026 | Change vs prior corresponding period |
|---|---|---|
| Total prescriptions | Not disclosed | +6% |
| Net sales | US$29.3 million | +8% |
The announcement states that the settlement highlights the validity and enforceability of the IMVEXXY® patent portfolio. That is the company’s own framing rather than an independent legal view.
Taken together, the figures show a product with growing prescriptions and net sales, alongside a defined generic entry date under the Teva settlement.
Commercial durability also rests on regulatory standing, and the FDA post-marketing requirement for IMVEXXY has now been confirmed as fulfilled, leaving no outstanding FDA post-marketing obligations for the product.
Strategy and next steps
Mayne Pharma stated it will continue to defend its IP estate and invest in access, adherence and prescriber engagement to maximise the product’s long-term contribution. The company said this supports its menopause portfolio and broader Women’s Health business.
Access and adherence efforts are also being built out through DistributeRx, the direct-to-patient fulfilment subsidiary launched in March 2026 to serve Women’s Health and Dermatology and support improved revenue quality.
The last expiring patent is due in February 2034. The settlement remains subject to court approval of its terms.
The announcement does not provide revenue guidance or quantify any financial impact from the settlement.
Mayne Pharma is an ASX-listed specialty pharmaceutical company that describes itself as a leader in dermatology and women’s health in the United States, and it also provides contract development and manufacturing services to clients worldwide.
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