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Data updated: May 26, 2026

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE (norepinephrine bitartrate)

Cardiovascular Approved 2021-01-15

Norepinephrine bitartrate is a catecholamine used to raise blood pressure in adult patients experiencing severe, acute hypotension. It helps patients with acute hypotensive states by restoring blood pressure to more stable levels. This medication is typically used in critical care settings where a rapid cardiovascular response is necessary to maintain systemic circulation.

Source: FDA Label • SAGENT

How NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Works

This medication works by constricting peripheral blood vessels through alpha-adrenergic activity and stimulating the heart's contraction strength. It also dilates the coronary arteries via beta-adrenergic action, which helps improve blood flow to the heart muscle while increasing overall blood pressure.

3
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2021-01-15
Patent Cliff
2041

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Active Ingredient: NOREPINEPHRINE BITARTRATE

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
21 FDA actions from 2021 to 2026
Mar 2026 ORIGINAL
Update
Feb 2026 SUPPL
Mfg · Manufacturing (CMC)
Aug 2025 ORIGINAL
Update

What NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Treats

1 indications

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypotension
Source: FDA Label

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT05836272 EA-NE-TUN Tunisian ICUs association Ph 4 recruiting Early Administration of Norepinephrine in Sepsis
NCT05521152 MD-12-2021 Ph 3 completed Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy
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Active Pipeline

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Key Completed Trials

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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.

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE FDA Label Details

Indications & Usage

FDA Label (PDF)

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE is indicated for the treatment of Hypotension.

View full patent landscape →
2 OB patents · 1 families · 10 international docs across 4 countries

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Patents & Exclusivity

Latest Patent: Mar 2041

Patents (2 active)

US12097170 Expires Mar 8, 2041
US12290494 Expires Mar 8, 2041
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2041
  • 15 active patents

Trial Analysis

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Competitive Landscape

  • 16 similar drugs
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Data Sources

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