
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.
How can we help you?
Receive insights into the latest events and regulatory updates
Sent directly to your email
Get industry insights and Unibest news here
Contact Us →