Exclusive Summary

• - Fully off-patent globally with broad generic entry since the mid-2010s, enabling rapid registration and distribution.
• - Large, aging AML and higher-risk MDS populations with multi-cycle HMA use drive steady, predictable demand.
• - Endorsed by NCCN/ELN/ESMO, including as a standard option with venetoclax for unfit AML.
• - Dual strengths (25 mg/50 mg) cut vial wastage for small-BSA/dose-adjustment patients and improve pharmacoeconomics.
• - Significant price headroom versus originator and oral alternatives supports competitive tender wins and access expansion.