Mayne Pharma Settles US Patent Litigation with Teva USA
Key points
- Settlement resolves IMVEXXY patent litigation with Teva
- Agreed market entry date for generic IMVEXXY set for 2 September 2032
- Settlement highlights validity and enforceability of IMVEXXY patent portfolio
Full summary
Mayne Pharma Group Limited (ASX: MYX) has settled the US Paragraph IV litigation with Teva Pharmaceuticals USA concerning IMVEXXY (estradiol vaginal inserts) and associated FDA Orange Book patents. The settlement resolves ongoing litigation, providing an agreed pathway for a generic product entry on 2 September 2032. The settlement does not include any financial payment or upfront monetary consideration. This settlement, along with a previous one with Sun Pharma, clarifies the generic entry landscape for IMVEXXY, removing litigation costs and uncertainties.
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