Data updated: Mar 10, 2026
XACDURO (COPACKAGED)
DURLOBACTAM SODIUM
Approved 2023-05-23
1
Indication
--
Phase 3 Trials
1
Priority Reviews
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-05-23
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
Companies
Website: ↗
XACDURO (COPACKAGED) Approval History
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What XACDURO (COPACKAGED) Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- 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.
XACDURO (COPACKAGED) FDA Label Details
ProXACDURO (COPACKAGED) Patents & Exclusivity
Latest Patent: Nov 2035
Exclusivity: May 2033
Patents (4 active)
US10376499
Expires Nov 17, 2035
US9968593
Expires Nov 17, 2035
US9623014
Expires Apr 2, 2033
US9309245
Expires Apr 2, 2033
Exclusivity
NCE
Until May 2028
GAIN
Until May 2033
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.