Unibest

Pipeline Database

UB205

Paroxetine Hydrochloride Enteric-coated Sustained-release Tablets

UB205

ProductParoxetine Hydrochloride Enteric-coated Sustained-release Tablets
Strength12.5mg; 25mg
IndicationsMajor depressive disorder; panic disorder; social anxiety disorder; premenstrual dysphoric disorder
TherapeuticsPsychiatry
GMPUS - FDA; CN - NMPA
RegistrationUnited States
ModalitiesSmall Molecule

Exclusive Summary

  • - Large, undertreated global populations in depression/anxiety and PMDD sustain steady SSRI demand; paroxetine CR covers MDD/PD/SAD/PMDD.
  • - Enteric-coated sustained-release design improves GI tolerability and adherence; 12.5/25 mg supports low-dose initiation and fine titration, differentiating from IR.
  • - Fully genericized with no patent barriers; typical 60–90% price discount versus originator in most markets.
  • - US-FDA GMP and US registration provide reusable CTD/BE package, enabling faster multi-country registrations and compliant market entry.
  • - Distribution-ready, ideal for partners with psychiatric/gynecology access and reimbursement capabilities to scale quickly.

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