Nitric Oxide Patent Expiration

Nitric Oxide is Used for treating pulmonary hypertension or hypoxia through nitric oxide delivery to the patient. It was first introduced by Mallinckrodt Pharmaceuticals Ireland Ltd in its drug Inomax on Dec 23, 1999. Another drug containing Nitric Oxide is Genosyl. 3 different companies have introduced drugs containing Nitric Oxide.


Nitric Oxide Patents

Given below is the list of patents protecting Nitric Oxide, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Genosyl US11672938 Start-up protocols for nitric oxide delivery device Jul 22, 2040 Vero Biotech Inc
Inomax US9770570

(Pediatric)

Apparatus and method for monitoring nitric oxide delivery Nov 03, 2036 Mallinckrodt Ireland
Inomax US9770570 Apparatus and method for monitoring nitric oxide delivery May 03, 2036 Mallinckrodt Ireland
Genosyl US10213572 Nitrogen dioxide storage cassette Feb 12, 2036 Vero Biotech Inc
Genosyl US10737051 Nitrogen dioxide storage device Oct 20, 2035 Vero Biotech Inc
Inomax US9279794

(Pediatric)

Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide Aug 19, 2035 Mallinckrodt Ireland
Inomax US9279794 Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide Feb 19, 2035 Mallinckrodt Ireland
Inomax US8291904

(Pediatric)

Gas delivery device and system Jul 06, 2031 Mallinckrodt Ireland
Inomax US8573209

(Pediatric)

Gas delivery device and system Jul 06, 2031 Mallinckrodt Ireland
Inomax US8573210

(Pediatric)

Nitric oxide delivery device Jul 06, 2031 Mallinckrodt Ireland
Inomax US8776794

(Pediatric)

Nitric oxide delivery device Jul 06, 2031 Mallinckrodt Ireland
Inomax US8776795

(Pediatric)

Gas delivery device and system Jul 06, 2031 Mallinckrodt Ireland
Inomax US9265911

(Pediatric)

Gas delivery device and system Jul 06, 2031 Mallinckrodt Ireland
Inomax US9295802

(Pediatric)

Gas delivery device and system Jul 06, 2031 Mallinckrodt Ireland
Inomax US9408993

(Pediatric)

Nitric oxide delivery device Jul 06, 2031 Mallinckrodt Ireland
Inomax US8291904 Gas delivery device and system Jan 06, 2031 Mallinckrodt Ireland
Inomax US8573209 Gas delivery device and system Jan 06, 2031 Mallinckrodt Ireland
Inomax US8573210 Nitric oxide delivery device Jan 06, 2031 Mallinckrodt Ireland
Inomax US8776794 Nitric oxide delivery device Jan 06, 2031 Mallinckrodt Ireland
Inomax US8776795 Gas delivery device and system Jan 06, 2031 Mallinckrodt Ireland
Inomax US9265911 Gas delivery device and system Jan 06, 2031 Mallinckrodt Ireland
Inomax US9295802 Gas delivery device and system Jan 06, 2031 Mallinckrodt Ireland
Inomax US9408993 Nitric oxide delivery device Jan 06, 2031 Mallinckrodt Ireland
Genosyl US8607785 Systems and devices for generating nitric oxide Jul 14, 2030 Vero Biotech Inc
Genosyl US11103669 Nitric oxide therapies Jun 21, 2030 Vero Biotech Inc
Inomax US11931377

(Pediatric)

Methods of administering inhaled nitric oxide gas Dec 30, 2029 Mallinckrodt Ireland
Inomax US8282966

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide Dec 30, 2029 Mallinckrodt Ireland
Inomax US8293284

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide Dec 30, 2029 Mallinckrodt Ireland
Inomax US8431163

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas Dec 30, 2029 Mallinckrodt Ireland
Inomax US8795741

(Pediatric)

Methods for treating patients who are candidates for inhaled nitric oxide treatment Dec 30, 2029 Mallinckrodt Ireland
Inomax US8846112

(Pediatric)

Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation Dec 30, 2029 Mallinckrodt Ireland
Genosyl US11511252 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Sep 21, 2029 Vero Biotech Inc
Genosyl US10926054 Systems and devices for generating nitric oxide Aug 13, 2029 Vero Biotech Inc
Genosyl US8944049 Systems and devices for generating nitric oxide Aug 13, 2029 Vero Biotech Inc
Genosyl US9604028 Systems and devices for generating nitric oxide Aug 13, 2029 Vero Biotech Inc
Inomax US11931377 Methods of administering inhaled nitric oxide gas Jun 30, 2029 Mallinckrodt Ireland
Inomax US8282966 Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide Jun 30, 2029 Mallinckrodt Ireland
Inomax US8293284 Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide Jun 30, 2029 Mallinckrodt Ireland
Inomax US8431163 Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas Jun 30, 2029 Mallinckrodt Ireland
Inomax US8795741 Methods for treating patients who are candidates for inhaled nitric oxide treatment Jun 30, 2029 Mallinckrodt Ireland
Inomax US8846112 Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation Jun 30, 2029 Mallinckrodt Ireland
Genosyl US9701538 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Jan 28, 2029 Vero Biotech Inc
Genosyl US7560076 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Apr 21, 2027 Vero Biotech Inc
Genosyl US7618594 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Oct 17, 2026 Vero Biotech Inc
Genosyl US7947227 Kit for the conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Oct 17, 2026 Vero Biotech Inc
Genosyl US8057742 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Jan 18, 2026

(Expired)

Vero Biotech Inc
Genosyl US10814092 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Oct 17, 2025

(Expired)

Vero Biotech Inc
Genosyl US10124142 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US11291793 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US11383059 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US11554241 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US8226916 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US8609028 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US8821801 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US9522249 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US9956373 Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) Aug 18, 2025

(Expired)

Vero Biotech Inc
Genosyl US6758214 Simple nitric oxide generator for ambulatory and/or bedside inhaled no treatment Feb 23, 2022

(Expired)

Vero Biotech Inc
Inomax US6125846

(Pediatric)

Purge system for nitric oxide administration apparatus Nov 16, 2017

(Expired)

Mallinckrodt Ireland
Inomax US5732693

(Pediatric)

Pause control of nitric oxide therapy Jun 13, 2017

(Expired)

Mallinckrodt Ireland
Inomax US5752504

(Pediatric)

System for monitoring therapy during calibration Jun 13, 2017

(Expired)

Mallinckrodt Ireland
Inomax US6125846 Purge system for nitric oxide administration apparatus May 16, 2017

(Expired)

Mallinckrodt Ireland
Inomax US5732693 Pause control of nitric oxide therapy Dec 13, 2016

(Expired)

Mallinckrodt Ireland
Inomax US5752504 System for monitoring therapy during calibration Dec 13, 2016

(Expired)

Mallinckrodt Ireland
Inomax US5558083

(Pediatric)

Nitric oxide delivery system May 22, 2014

(Expired)

Mallinckrodt Ireland
Inomax US5558083 Nitric oxide delivery system Nov 22, 2013

(Expired)

Mallinckrodt Ireland
Inomax US5485827

(Pediatric)

Methods and devices for treating plumonary vasoconstriction and asthma Jul 23, 2013

(Expired)

Mallinckrodt Ireland
Inomax US5873359

(Pediatric)

Methods and devices for treating pulmonary vasoconstriction and asthma Jul 23, 2013

(Expired)

Mallinckrodt Ireland
Inomax US5485827 Methods and devices for treating plumonary vasoconstriction and asthma Jan 23, 2013

(Expired)

Mallinckrodt Ireland
Inomax US5873359 Methods and devices for treating pulmonary vasoconstriction and asthma Jan 23, 2013

(Expired)

Mallinckrodt Ireland



Nitric Oxide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Nitric Oxide:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma Université de Sherbrooke NA RECRUITING
(Sep 1, 2026)
PHASE3
NO During CPB in Neonates to Reduce Risk of AKI Children's Hospital Medical Center, Cincinnati NA RECRUITING
(Aug 1, 2026)
PHASE3
Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women Colorado State University NA COMPLETED
(Aug 1, 2026)
PHASE1, PHASE2
Nitrite Supplementation in Long COVID Patients VA Office of Research and Development NA COMPLETED
(Aug 1, 2026)
PHASE2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults UConn Health NA RECRUITING
(Aug 1, 2026)
PHASE2
Beetroot Juice for Boosting Immunity During a Time of Stress. Baylor University NA COMPLETED
(Aug 1, 2026)
PHASE2
Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers Regina Elena Cancer Institute NA RECRUITING
(Aug 1, 2026)
PHASE3
Genistein for the Reduction of Adverse Cardiovascular Events (GRACE) London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Ginger's Therapeutic Potential in Asthma Emily DiMango, MD NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD University of Alberta NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD University of Alberta NA RECRUITING
(Jul 1, 2026)
PHASE2
The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina Pectoris Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) NA COMPLETED
(Jul 1, 2026)
PHASE2
Response to Exercise and Nitric Oxide in PAD Northwestern University NA RECRUITING
(Jul 1, 2026)
PHASE2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression West China Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants NICHD Neonatal Research Network NA COMPLETED
(Jun 1, 2026)
PHASE3
Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation Montreal Heart Institute NA RECRUITING
(Jun 1, 2026)
PHASE2
Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury University of Pennsylvania NA ENROLLING BY INVITATION
(Jun 1, 2026)
PHASE2
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease University Hospital, Rouen NA RECRUITING
(Jun 1, 2026)
PHASE2
Impact of Sotatercept on Pulmonary Artery and Right Ventricle Remodeling Imaging Assessed With 68Ga-FAPI PET/CT in Patients With PAH University Hospital, Brest NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Effect of a Daily Supplement on Plasma PAI-1 Levels University of California, Los Angeles NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans Vanderbilt University Medical Center NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
The COCOA-PAD II Trial Northwestern University NA RECRUITING
(May 1, 2026)
PHASE3
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF) Washington University School of Medicine NA RECRUITING
(May 1, 2026)
PHASE2
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH VA Office of Research and Development NA RECRUITING
(May 1, 2026)
PHASE2
NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers NOxy Health Products, LLC NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass Xijing Hospital NA RECRUITING
(May 1, 2026)
PHASE3
Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women. Universidad de Guanajuato NA COMPLETED
(May 1, 2026)
PHASE3
The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication Louis Messina NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI Simon Fraser University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Inhaled Nitric Oxide in Acute Ischemic Stroke Patients Undergoing Mechanical Thrombectomy Wake Forest University Health Sciences NA RECRUITING
(Apr 1, 2026)
PHASE1
Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis Sanotize Research and Development corp. NA COMPLETED
(Apr 1, 2026)
PHASE2
Vasodilator and Exercise Study for DMD (VASO-REx) University of Florida NA RECRUITING
(Apr 1, 2026)
PHASE2
Novel Approaches for Improving Vascular Function in Veterans With HFpEF VA Office of Research and Development NA RECRUITING
(Apr 1, 2026)
PHASE1
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease Suvankar Majumdar NA RECRUITING
(Apr 1, 2026)
PHASE2
Phase Ib of L-NMMA and Pembrolizumab The Methodist Hospital Research Institute NA COMPLETED
(Mar 1, 2026)
PHASE1
Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Massachusetts General Hospital NA TERMINATED
(Mar 1, 2026)
PHASE2
NO Prevention of COVID-19 for Healthcare Providers Massachusetts General Hospital NA TERMINATED
(Mar 1, 2026)
PHASE2
Effect of iNO in Patients With Submassive and Massive PE University of California, Los Angeles NA WITHDRAWN
(Mar 1, 2026)
PHASE2
L-Citrulline and Endothelial Function University of Oklahoma NA COMPLETED
(Mar 1, 2026)
PHASE1
Nebulised RESP30X Nitric Oxide Formulations in NCFB Patients With Pseudomonas Aeruginosa (Pa) Thirty Respiratory Limited NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
iNO300 Therapy in Critically Ill Patients With Pneumonia Massachusetts General Hospital NA RECRUITING
(Mar 1, 2026)
EARLY PHASE1
Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction Ankara City Hospital Bilkent NA RECRUITING
(Mar 1, 2026)
PHASE2, PHASE3


Nitric Oxide Generic API Manufacturers

Several generic applications have been filed for Nitric Oxide. The first generic version for Nitric Oxide was by Vero Biotech Inc and was approved on Oct 2, 2018. And the latest generic version is by Airgas Therapeutics Llc and was approved on Jul 27, 2023.

Given below is the list of companies who have filed for Nitric Oxide generic, along with the locations of their manufacturing plants worldwide.