NITRIC OXIDE - Generic Drug Details

What are the generic sources for nitric oxide and what is the scope of patent protection?

Nitric oxide is the generic ingredient in four branded drugs marketed by Vero Biotech Inc, Mallinckrodt Ireland, and Airgas Therap, and is included in four NDAs. There are thirty-one patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nitric oxide has one hundred and seventy-five patent family members in fifteen countries.

There are six drug master file entries for nitric oxide. Four suppliers are listed for this compound.

Summary for NITRIC OXIDE

International Patents:	175
US Patents:	31
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	1,110
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NITRIC OXIDE
What excipients (inactive ingredients) are in NITRIC OXIDE?	NITRIC OXIDE excipients list
DailyMed Link:	NITRIC OXIDE at DailyMed

Recent Clinical Trials for NITRIC OXIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Gary Van Guilder	EARLY_PHASE1
VA Office of Research and Development	PHASE2
Western University, Canada	PHASE4

See all NITRIC OXIDE clinical trials

Pharmacology for NITRIC OXIDE

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for NITRIC OXIDE

Bronchodilator Agents

Endothelium-Dependent Relaxing Factors

Free Radical Scavengers

Gasotransmitters

Neurotransmitter Agents

Anatomical Therapeutic Chemical (ATC) Classes for NITRIC OXIDE

R07AX	Other respiratory system products
R07A	OTHER RESPIRATORY SYSTEM PRODUCTS
R07	OTHER RESPIRATORY SYSTEM PRODUCTS
R	Respiratory system

Paragraph IV (Patent) Challenges for NITRIC OXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INOMAX	for Inhalation	nitric oxide	100 ppm and 800 ppm	020845	1	2014-05-20

US Patents and Regulatory Information for NITRIC OXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Vero Biotech Inc	NOXIVENT	nitric oxide	GAS;INHALATION	207141-002	Oct 2, 2018	AA	RX	No	No
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes			Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y

Expired US Patents for NITRIC OXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019

EU/EMA Drug Approvals for NITRIC OXIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Linde Healthcare AB	INOmax	nitric oxide	EMEA/H/C/000337INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.	Authorised	no	no	no	2001-08-01

International Patents for NITRIC OXIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2018038836	一酸化窒素送出を監視する装置および方法 (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY)
Japan	6732654
Canada	2734788	SYSTEMES ET DISPOSITIFS PERMETTANT LA GENERATION D'OXYDE NITRIQUE (SYSTEMS AND DEVICES FOR GENERATING NITRIC OXIDE)
Japan	5952341
Canada	3130908	PROCEDES DESTINES AU TRAITEMENT DES NOUVEAU-NES A TERME OU PRESQUE A TERME ATTEINTS D'UNE INSUFFISANCE RESPIRATOIRE HYPOXIQUE ASSOCIEE A DES SIGNES CLINIQUES OU ECHOCARDIOGRAPHIQUES D'HYPERTENSION PULMONAIRE (METHODS OF TREATING TERM AND NEAR-TERM NEONATES HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION)
European Patent Office	3308820	APPAREIL DE SURVEILLANCE DE L'ADMINISTRATION D'OXYDE NITRIQUE (APPARATUS FOR MONITORING NITRIC OXIDE DELIVERY)
Japan	2014505536	ガス送出装置およびシステム

Supplementary Protection Certificates for NITRIC OXIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0786264	SPC/GB08/019	United Kingdom		PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801

Market Dynamics and Financial Trajectory for Nitric Oxide (Pharmaceutical)

Last updated: April 24, 2026

What is “nitric oxide” as a pharmaceutical market asset?

“Nitric oxide” in pharma is not a single branded small molecule. It is an inhaled therapeutic gas delivered via proprietary delivery systems and sold under dosing protocols tied to patient setting. The commercial product category is dominated by:

• Inhaled nitric oxide (iNO) for hypoxic respiratory failure and pulmonary hypertension syndromes in neonates and related acute indications.
• Delivery equipment and service-linked revenue that can materially affect total spend for hospital buyers.
• Usage patterns concentrated in acute-care settings, which drives payment cycles, procurement behavior, and inventory risk.

The clearest market anchor for commercially standardized iNO is INOmax (nitric oxide, 100% premixed gas, delivered for inhalation), long sold for neonatal respiratory failure and pulmonary hypertension indications.

How does demand form and where does it concentrate?

Core demand drivers

Demand for inhaled nitric oxide tracks four operational and clinical variables:

1. Neonatal acuity volumes: admissions and NICU occupancy drive the base opportunity.
2. Protocol adoption: hospitals adopt iNO based on guideline alignment, competing rescue therapies, and clinician practice.
3. Duration of use per treated case: iNO utilization is typically episodic rather than chronic, which constrains lifetime demand per patient.
4. Substitution pressure: competing pulmonary vasodilators and supportive ventilatory strategies can reduce uptake at the margin.

Where spend lands

Spend lands in hospitals that:

• run NICUs and pediatric intensive care units,
• have ventilator-compatible nitric oxide delivery workflows,
• have contracting arrangements for gas supply and delivery systems.

Procurement is typically tender-driven with supplier qualification and system compatibility steps, which can extend switching timelines.

What competitive forces shape pricing and margins?

Bargaining power of buyers

• High buyer sophistication: hospitals understand dosing cost-per-hour, device lease terms, and wastage.
• Comparative economics: buyers compare total cost of treatment episodes (gas + delivery + service + disposables) across suppliers.
• Switching costs are real: compatibility with delivery equipment and staff training reduces churn, but does not eliminate it.

Threat of new entrants

• The product is operationally and regulatorily complex (gas handling, device integration, and manufacturing standards).
• New gas-only entrants face barriers because hospitals buy the system-of-care, not gas in isolation.

Substitution

Substitution risk increases when clinicians can achieve hemodynamic response via:

• ventilatory optimization,
• alternative pulmonary vasodilators,
• evolving care pathways that reduce rescue therapy exposure.

How does regulation and reimbursement affect the financial trajectory?

Regulatory positioning

Nitric oxide is a medicine with device-linked delivery. That structure impacts:

• labeling scope,
• post-market safety monitoring,
• clinical guideline incorporation.

Reimbursement dynamics

Hospital reimbursement varies by country, but the practical effect is consistent:

• iNO is treated as an acute inpatient therapy,
• payment is typically bundled or case-based in many systems, shifting supplier leverage toward negotiated contracting discounts.

Market trend inflection points that matter financially

Even without a single consolidated “nitric oxide pharma market” figure across all jurisdictions, the commercial reality for iNO is that financial performance moves with:

• NICU volume cycles and population-level birth trends,
• policy and guideline shifts that change thresholds for iNO initiation,
• competition in delivery systems and procurement contracting rounds,
• supply continuity risk (gas production and distribution),
• uptake changes for branded vs. lower-cost supplied options.

The dominant branded anchor, INOmax, has historically reflected the category’s billing pattern: episodic acute-care demand rather than durable chronic revenue.

Financial trajectory: how revenues and growth usually behave in this category

Revenue pattern

For inhaled nitric oxide, revenue typically shows a three-part profile:

1. Baseline demand: steady acute-care cases treated each year.
2. Contracted sales swings: procurement cycles cause step-changes in installed accounts.
3. Protocol-driven volatility: changes in treatment criteria can move usage per case.

Margin structure

Margin is shaped by:

• manufacturing and distribution economics for compressed gas,
• price concessions driven by hospital tendering,
• device/service bundling intensity (where offered),
• wastage and dosing efficiency.

INOmax as the primary financial reference point

INOmax is the long-standing commercial iNO product. Its financial implications for the category:

• Revenue is anchored to acute use in neonatal pulmonary hypertension and related respiratory failure contexts.
• Growth depends more on account expansion and contract renewal than on new patient populations.

Indication footprint

INOmax is indicated for:

• neonates with hypoxic respiratory failure where iNO reduces the risk of death or the need for extracorporeal membrane oxygenation (ECMO), and
• neonates with pulmonary hypertension.

This matters financially because the eligible population is tied to NICU diagnoses and severity thresholds.

Product safety, labeling, and how that impacts sales

Safety labeling affects:

• clinician willingness to use early,
• payer comfort in contracting at volume,
• protocol enforcement.

Nitric oxide carries risks associated with:

• methemoglobinemia and nitrogen dioxide formation when improperly controlled,
• rebound pulmonary hypertension if discontinued abruptly,
• monitoring requirements that can reduce “overuse” and concentrate use among trained settings.

Those constraints tighten utilization patterns and can limit “rapid scale” but support stable contracting once systems are in place.

What does the market pay for: gas, delivery systems, and service?

Hospital buyers typically evaluate total cost, not just drug price. The economic levers include:

• Cost per delivered treatment hour
• Device compatibility and training costs
• Maintenance and service terms
• Supply logistics and lead times
• Operational monitoring equipment requirements

Because the therapy is used in acute settings with time-sensitive workflows, procurement often prioritizes reliability and integration over headline unit price.

Scenario analysis: the direction of financial outcomes

Upside scenarios

• Expansion of NICU capacity or improved survival rates that increase the number of treated episodes.
• Guideline incorporation that increases eligible use.
• Contract renewals that lock in stable pricing and supply terms.

Downside scenarios

• Protocol tightening that reduces the number of patients started on iNO.
• Intensified tendering and price pressure from alternative suppliers or competing therapies.
• Supply disruptions that limit availability and reduce treated counts.

Key Takeaways

• Nitric oxide’s pharmaceutical market is dominated by inhaled acute-care use with strong concentration in NICUs and pediatric intensive care; revenue behaves like a contracted episodic therapy rather than a chronic drug.
• Financial trajectory is driven less by long-term adoption curves and more by hospital contracting cycles, guideline thresholds for initiation, and total treatment economics (gas plus delivery systems and service).
• Competitive forces center on switching costs in delivery equipment and substitution pressure from alternative pulmonary vasodilator or ventilatory strategies.
• The category’s margin structure depends on gas manufacturing and distribution economics and device/service bundling, with pricing renegotiated through tender dynamics.

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FAQs

1) What determines year-to-year demand for inhaled nitric oxide?

NICU admission and acuity volumes, clinician thresholds for initiating iNO, and average duration of use per treated episode.

2) Why do delivery systems and service terms matter financially?

Because hospitals procure the therapy as a workflow. Gas price alone does not capture total cost of delivered treatment, training, maintenance, and downtime risk.

3) Is growth likely to come from new indications?

Historically, the commercial pattern is anchored to existing acute-care indications. Revenue growth tends to come more from account and contracting dynamics than broad indication expansion.

4) What is the biggest pricing pressure channel?

Hospital procurement tenders that benchmark total treatment cost across suppliers and can drive step-down pricing at contract renewal.

5) What safety factors influence usage patterns and commercial uptake?

Monitoring requirements and risks tied to methemoglobinemia, nitrogen dioxide formation, and rebound effects can reduce casual use and concentrate therapy in trained settings.

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References

[1] U.S. Food and Drug Administration. (n.d.). INOmax (nitric oxide) prescribing information. FDA. https://www.accessdata.fda.gov/