Unibest

Pipeline Database

UB196

Bupropion Hydrochloride Extended-Release Tablets

UB196

ProductBupropion Hydrochloride Extended-Release Tablets
Strength150mg; 300mg
IndicationsDepression; seasonal affective disorder
TherapeuticsPsychiatry
GMPUS - FDA; CN - NMPA
RegistrationUnited States
ModalitiesSmall Molecule

Exclusive Summary

  • - Fully off-patent and US-registered mature product, ready for rapid multi-country rollout.
  • - Addresses high-burden populations in MDD, SAD, and smoking cessation with strong, persistent demand.
  • - FDA-GMP and US registration de-risk quality/BE, especially for the historically sensitive 300 mg XL strength.
  • - Once-daily 150/300 mg XL improves adherence and offers favorable weight/sexual side-effect profile vs many SSRIs.
  • - >90% price discount vs originator enables tender wins and payer adoption with clear volume upside.

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