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Utebzi

(Tebipenem Pivoxil)

Small molecule

GGlaxo Dba Glaxosmithkline

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Clinical

Trials by Indication[1]

Shigellosis1 trial

Tebipenem-pivoxil as an Alternative to Ceftriaxone for Clinically Non-responding Children With Shigellosis: a Randomized Non-inferiority Trial

Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 2·NCT05121974·132 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 16, 2026

UTEBZI

NDA NDA215960

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Tebipenem Pivoxil. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tebipenem Pivoxil compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA215960). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Utebzi. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[4]

Patent Cliff

Dec 14, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12226403Dec 14, 2037

10889587Feb 5, 2038

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