Data updated: Mar 29, 2026
EXBLIFEP
CEFEPIME HYDROCHLORIDE
Approved 2024-02-22
1
Indication
--
Phase 3 Trials
1
Priority Reviews
2
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2024-02-22
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
EXBLIFEP Approval History
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What EXBLIFEP Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
ProEXBLIFEP 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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.