TheraRadar
Data updated: May 26, 2026

NOURESS (cysteine hydrochloride)

Hepatology Approved 2019-12-13
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market

Details

Status
Discontinued
First Approved
2019-12-13
Patent Cliff
2039

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Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Baxter
Active Ingredient: CYSTEINE HYDROCHLORIDE

NOURESS Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Dec 2019 ORIGINAL Priority
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What NOURESS Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • 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.

NOURESS FDA Label Details

View full patent landscape →
19 OB patents · 2 families · 33 international docs across 2 countries

NOURESS Patents & Exclusivity

Latest Patent: Mar 2039

Patents (19 active)

US10543186 Expires Mar 15, 2039
US11045438 Expires Mar 15, 2039
US10493051 Expires Mar 15, 2039
US10702490 Expires Mar 15, 2039
US11510941 Expires Mar 2, 2039
US10478453 Expires Jan 15, 2039
US10583155 Expires Jan 15, 2039
US11510942 Expires Jan 15, 2039
US11826383 Expires Jan 15, 2039
US10905714 Expires Jan 15, 2039
US11642370 Expires Jan 15, 2039
US10918662 Expires Jan 15, 2039
US11648262 Expires Jan 15, 2039
US11679125 Expires Jan 15, 2039
US10653719 Expires Jan 15, 2039
US10912795 Expires Jan 15, 2039
US10933089 Expires Jan 15, 2039
US10905713 Expires Jan 15, 2039
US11684636 Expires Jan 15, 2039
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2039
  • • 19 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: NDA212535 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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