Unibest

UB459

ProductDaptomycin for Injection
Strength350mg,500mg
IndicationsComplicated skin and soft tissue infection; Staphylococcal bacteraemia; Infective endocarditis
TherapeuticsInfectious Diseases
GMPUS - FDA; EU - EMA
RegistrationUnited States; EU
ModalitiesPeptide

Exclusive Summary

  • - Global exclusivity has expired; since 2016–2018 the US/EU have been open to generics, enabling rapid distribution without patent barriers.
  • - Targets high-value inpatient MRSA indications (bacteremia/right-sided endocarditis and cSSTI) with guideline-backed use and steady demand.
  • - Dual strengths (350 mg and 500 mg) support weight-based dosing and pediatrics, reducing pharmacy waste and total treatment cost.
  • - US and EU-27 registrations demonstrate FDA/EMA-level quality and compliance, facilitating reliance pathways and tender participation across markets.
  • - Post-LOE pricing typically 60–80% below the originator, materially lowering multi-week therapy costs in hospital care.

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