TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

INOMAX

NITRIC OXIDE
Cardiovascular Approved 1999-12-23
3
Indications
--
Phase 3 Trials
2
Priority Reviews
26
Years on Market

Details

Status
Prescription
First Approved
1999-12-23
Routes
INHALATION
Dosage Forms
GAS

Companies

Active Ingredient: NITRIC OXIDE

INOMAX Approval History

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What INOMAX Treats

2 indications

INOMAX is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypoxic Respiratory Failure
  • Pulmonary Hypertension
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

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.

INOMAX FDA Label Details

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Indications & Usage

FDA Label (PDF)

INOmax ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. INOmax is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence ...

INOMAX Patents & Exclusivity

Latest Patent: Nov 2036

Patents (159 active)

US9770570*PED Expires Nov 3, 2036
US9770570 Expires May 3, 2036
US9279794*PED Expires Aug 19, 2035
US9279794 Expires Feb 19, 2035
US8291904*PED Expires Jul 6, 2031
US8776795*PED Expires Jul 6, 2031
US8776794*PED Expires Jul 6, 2031
US8573209*PED Expires Jul 6, 2031
US8573210*PED Expires Jul 6, 2031
US9295802*PED Expires Jul 6, 2031
+ 149 more patents
Source: FDA Orange Book

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Data Sources

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