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Exxua

(Gepirone)

Small molecule

PPierre Fabre Medicament

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Clinical

Trials by Indication[1]

Cocaine Dependence1 trial

Gepirone vs Placebo in Treatment of Cocaine Dependence - 3

Completed·UUniversity of Pennsylvania·Phase 2·NCT00000189·41 enrolled

Regulatory

FDA Approval Timeline[3]

Sep 22, 2023

EXXUA

NDA NDA021164

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Gepirone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gepirone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA021164). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Exxua. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pierre Fabre Medicament company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PPierre Fabre Medicament

Patent Landscape[4]

Patent Cliff

Sep 2, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7538116Sep 2, 2030

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