TheraRadar
Data updated: Nov 8, 2026

NEXIUM IV (esomeprazole sodium) · AstraZeneca

Gastrointestinal Approved 2005-03-31

NEXIUM IV is FDA-approved to treat 4 conditions (same as ESOMEPRAZOLE SODIUM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
1
Priority Reviews
21
Years on Market

Details

Status
Discontinued
First Approved
2005-03-31
Revenue
$190M (Q4-2025)

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Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

AstraZeneca
Active Ingredient: ESOMEPRAZOLE SODIUM

NEXIUM IV Approval History

2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
58 FDA actions from 2005 to 2023 · 2 indication expansions
Jul 2023 SUPPL
Label · Labeling
FDA Letter Label
Mar 2022 SUPPL
Label · Labeling
FDA Letter Label
Nov 2020 SUPPL
Label · Labeling
FDA Letter Label

What NEXIUM IV Treats

4 indications

NEXIUM IV is approved for 4 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ESOMEPRAZOLE SODIUM (same active ingredient).

Source: FDA Label
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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.

NEXIUM IV FDA Label Details

Indications & Usage

FDA Label (PDF)

NEXIUM IV is FDA-approved to treat 4 conditions — same approved indications as ESOMEPRAZOLE SODIUM.

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Revenue Insights

  • • Q4-2025: $190M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA021689 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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