Exclusive Summary

• - Global patents expired (US 2008, EU mid-2000s); 70 mg once-weekly is the mainstream dose with low switching/education cost.
• - >200 million people affected worldwide and ~8.9 million fragility fractures annually; aging drives steady and growing demand.
• - Listed on the WHO Model List and recommended as first-line oral bisphosphonate in multiple guidelines with proven fracture risk reduction.
• - US-FDA GMP strengthens access and tender eligibility in reliance markets, fitting a Distribution go-to-market.
• - >90% price erosion versus originator; 4-tablet monthly packs support low-cost supply and efficient inventory turnover.