TheraRadar
Data updated: May 26, 2026

EXBLIFEP (cefepime hydrochloride)

Priority Review Fast Track
Infectious Disease Approved 2024-02-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
2
Years on Market

Details

Status
Discontinued
First Approved
2024-02-22
Patent Cliff
2034

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

ORCHID PHARMA
Active Ingredient: CEFEPIME HYDROCHLORIDE , ENMETAZOBACTAM

EXBLIFEP Approval History

2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Feb 2024 ORIGINAL Priority
Update · Type 1 - New Molecular Entity and Type 4 - New Combination
FDA Letter Label

What EXBLIFEP Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01484015 IRB00015247 NCI-2011-02422, CCCWFU 02110 Ph 1 completed Prolonged or Standard Infusion of Cefepime Hydrochloride in Treating Patients With Febrile Neutropenia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

EXBLIFEP FDA Label Details

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2 OB patents · 2 families · 38 international docs across 20 countries

EXBLIFEP Patents & Exclusivity

Latest Patent: Nov 2034
Exclusivity: Feb 2034

Patents (2 active)

US11124526 Expires Nov 7, 2034
US7687488 Expires Dec 3, 2027

Exclusivity

NCE Until Feb 2029
GAIN Until Feb 2034
Source: FDA Orange Book

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Deep insights for EXBLIFEP

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2034
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA216165 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.