TheraRadar
Data updated: Jul 17, 2026

EPHEDRINE SULFATE · Hikma

Cardiovascular Approved 2016-04-29

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

20
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-04-29
Patent Cliff
2040

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

EPHEDRINE SULFATE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
33 FDA actions from 2017 to 2026
Jul 2026 ORIGINAL
Update
Mar 2026 ORIGINAL
Update
Dec 2025 ORIGINAL
Update

What EPHEDRINE SULFATE Treats

1 indications

EPHEDRINE SULFATE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as CORPHEDRA (same active ingredient).

Source: FDA Label
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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.

EPHEDRINE SULFATE FDA Label Details

Indications & Usage

FDA Label (PDF)

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine sulfate injection is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

View full patent landscape →
2 OB patents · 1 families · 7 international docs across 2 countries

EPHEDRINE SULFATE Patents & Exclusivity

Latest Patent: Jan 2040

Patents (2 active)

US12029710 Expires Jan 22, 2040
US10869845 Expires Jan 22, 2040
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2040
  • 6 active patents

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Data Sources

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