Exclusive Summary

• - IP and data exclusivities have expired globally; generics are present in the EU while the drug is not approved in the US, leaving room to expand in non-EU and emerging markets.
• - The burden of preterm birth is high (about 13.4 million in 2020), with steady hospital demand for 48-hour acute tocolysis.
• - Multiple guidelines list atosiban as a key option for acute tocolysis, with better maternal safety than beta-agonists and use when nifedipine is contraindicated or not tolerated.
• - China’s first-to-market generic achieved up to 70% peak share, validating quality and acceptance; the SKUs match global dosing (0.9 mL: 6.75 mg; 5 mL: 37.5 mg).
• - Compared with the originator, a 30–60% total treatment cost reduction is typically achievable, supporting tenders and access.

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