Exclusive Summary

• - Fully off-patent globally with broad generic entry since 2017, enabling flexible distribution-led launches.
• - Addresses stable inpatient demand for MDR Gram-negative complicated infections; listed on WHO EML and AWaRe Reserve with clear clinical niche.
• - EU registration across 27 countries ensures EU-GMP/QP compliance and immediate access to pan-EU tenders and hospital channels.
• - Generics typically offer 60–90% price reduction versus originator, strengthening tender competitiveness and lowering total care costs.
• - Practical second-line/combination option for CRE/CRAB where newer agents are inaccessible or insufficiently covered.