Exclusive Summary

• - Off-patent globally with fewer competitors in granules than tablets; EMA filing enables multi-country entry windows.
• - UC patient pool ~3–4 million worldwide; 5-ASA is first-line for most mild–moderate cases, driving steady, high-repeat demand.
• - GR prolonged-release granules (0.5 g/1.5 g) support once- or split-dosing, ease swallowing, and enable precise titration to improve adherence.
• - EU granule market remains oligopolistic (Salofalk/Pentasa/Asacol/Octasa), offering differentiation and margin versus crowded tablets.
• - 50–70% price savings versus originators support both tender and retail expansion.