TheraRadar
Data updated: May 26, 2026

XACDURO (COPACKAGED) (durlobactam sodium)

Priority Review Fast Track
Infectious Disease Approved 2023-05-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
3
Years on Market

Details

Status
Prescription
First Approved
2023-05-23
Patent Cliff
2035

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

ENTASIS THERAP
Active Ingredient: DURLOBACTAM SODIUM , DURLOBACTAM SODIUM , SULBACTAM SODIUM

XACDURO (COPACKAGED) Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
May 2023 ORIGINAL Priority
Update · Type 1 - New Molecular Entity and Type 4 - New Combination
FDA Letter Label

What XACDURO (COPACKAGED) Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
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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.

XACDURO (COPACKAGED) FDA Label Details

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4 OB patents · 2 families · 103 international docs across 45 countries

XACDURO (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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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 4 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: NDA216974 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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