
UB585
ProductLevetiracetam Extended-release Tablets
Strength500mg; 750mg
IndicationsPartial seizures
TherapeuticsNeurology
GMPUS - FDA
RegistrationUnited States
ModalitiesSmall Molecule
Exclusive Summary
- The product has obtained US FDA GMP certification and is registered in the US, indicating high international quality standards and readiness to meet global demand for quality generics.
- Levetiracetam Extended-release Tablets, as a first-line antiepileptic drug and listed in the WHO Essential Medicines List, has significant clinical demand and broad market acceptance globally.
- The generic product offers a clear cost advantage over the originator drug, providing partners with better profit margins and market competitiveness.
- Despite being in a competitive market due to the expiration of originator patents, its efficacy and extended-release formulation offer a strong position in regions with high unmet needs for epilepsy treatment.
- The Chinese supplier, seeking distribution partnerships, can leverage the product's existing registrations and certifications to quickly enter target markets and reduce time-to-market.
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