Exclusive Summary

• - Patent cliff is open in many markets (EU/UK/Canada/Australia already have generics) with U.S. entry expected in 2027–2028, enabling a staged go-to-market plan.
• - Covers the full advanced prostate cancer continuum (mHSPC/nmCRPC/mCRPC) with strong guideline endorsement and sustained, inelastic demand.
• - US-FDA GMP and U.S. registration experience support fast-track registration, tenders, and access in SRA-reliant markets.
• - Dual strengths 40mg/80mg reduce pill burden (2×80mg) and enable dose reduction (e.g., 120mg), improving hospital stocking and prescribing flexibility.
• - Significant cost savings vs originator (commonly 50–80% or more) support payer negotiations and rapid uptake.