| Region | Designation | Benefit | |--------|-------------|---------| | | Orphan‑drug (2025), Fast Track (2026), Breakthrough Therapy (anticipated) | 7‑year market exclusivity, 10 % tax credit for clinical testing, priority review (6 months) | | European Union | Orphan‑drug (2025), PRIME (2026) | 10‑year exclusivity, fee reductions, accelerated scientific advice | | Japan | SAKIGAKE (anticipated) | Early conditional approval, 8‑year exclusivity | | Australia/Canada | Incentive programs for AMR agents (e.g., Australian Therapeutic Goods Administration) | Reduced fees, possible market exclusivity extensions |
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| Patent | Scope | Expiry | |--------|-------|--------| | – Core peptide sequence & cyclization methodology | US, Canada, EU, JP, AU | 2037 | | US 11,012,004 – Oral formulation & enteric coating | US, EU, CN | 2039 | | WO 2023/125678 – Combination therapy with β‑lactamase inhibitor | World (PCT) | 2035 | | US 2026/018934 – Manufacturing process (continuous SPPS) | US, EU | 2042 | Fast Track (2026)