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, Linde Gas Equip, 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:	4
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	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
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

Expired US Patents for nitric oxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
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
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999

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	2020187129	一酸化窒素に曝される電気化学ガスセンサーの長期の感度変動を補償する方法 (METHOD FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE)
World Intellectual Property Organization (WIPO)	2010021942
Canada	2734788	SYSTEMES ET DISPOSITIFS PERMETTANT LA GENERATION D'OXYDE NITRIQUE (SYSTEMS AND DEVICES FOR GENERATING NITRIC OXIDE)
Japan	2015013118
World Intellectual Property Organization (WIPO)	2016064928

Supplementary Protection Certificates for nitric oxide

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

Market Dynamics and Financial Trajectory for Nitric Oxide Drugs

Last updated: February 19, 2026

What is the Current Market for Nitric Oxide Therapeutics?

The nitric oxide (NO) drug market is driven by its application in critical care, cardiology, and respiratory conditions. NO is a vasodilator used to treat pulmonary hypertension and improve oxygenation in newborns and adults. The global market size was valued at approximately $930 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030, reaching roughly $1.5 billion.

What Factors Influence Market Growth?

• Regulatory Approvals: Key approvals in the United States, Europe, and Asia expand the market. For example, INOmax (nitric oxide) by Mallinckrodt remains the dominant product approved by FDA since 1999.
• R&D Investment: Increased investment in inhaled NO and alternative delivery systems broadens potential indications.
• Emerging Indications: Research into NO for neuroprotection, wound healing, and cancer treatment opens new revenue streams.
• COVID-19 Impact: The pandemic highlighted NO's role in respiratory therapy. Enhanced demand positively affected sales but also increased competition.

Who Are the Leading Players?

Company	Key Drugs	Market Share (Estimated 2022)	Notable R&D Projects	Geographies Covered
Mallinckrodt	INOmax	70%	Inhaled NO for ARDS, COVID-19	Global, with focus on North America
Ikaria	NO therapeutic pipeline	15%	Investigating NO for neurovascular disorders	North America, Europe
Others	Various	15%	Alternative NO donors; inhalation systems	Asia, Europe

How Do Regulatory Policies Shape the Market?

• FDA Approvals: INOmax remains FDA-approved for neonatal pulmonary hypertension; no new inhaled NO drugs have gained approval since 2010.
• EMA and Other Authorities: Similar regulatory pathways, with approval mainly for oxygenation-related indications.
• Companion Regulations: Use of inhaled NO in COVID-19 treatments prompted emergency use authorizations temporarily, though no permanent approvals issued.

What Are the Key Clinical and Financial Risks?

• Developmental Risks: Limited pipeline activity due to challenges in drug delivery and stability.
• Market Competition: Pending therapies such as soluble guanylate cyclase stimulators and other vasodilators.
• Pricing Policies: Reimbursement rates vary by country, affecting profitability.
• Patent Expiry: INOmax's patent expiration in the late 2020s could open territory for generics or biosimilars.

What Is the Financial Outlook?

• Revenue Trends: Stable sales driven by existing product INOmax; growth driven by isolated clinical applications.
• R&D Costs: High, due to complexities in inhalation drug formulations and delivery devices.
• Market Entry Barriers: Strict regulatory standards and high clinical trial costs constrain new entrants, limiting competition and maintaining premium prices for approved drugs.

What Are the Main Opportunities and Challenges?

Opportunities:

• Expansion into new therapeutic areas (neurology, wound healing).
• Development of more efficient delivery systems lowering costs.
• Increasing use in emerging markets with expanding healthcare infrastructure.

Challenges:

• Technical challenges associated with NO administration and stability.
• Limited pipeline activity reduces future growth potential.
• Price regulation and reimbursement limitations.

Summary

The nitric oxide drug market is mature but expanding slightly driven by new clinical applications and increased healthcare infrastructure. The revenue forecast remains stable, with growth primarily dependent on pipeline innovations and regulatory changes. Dominated by a few companies, especially Mallinckrodt, the market faces potential patent cliffs and competitive pressure from alternative therapies.

Key Takeaways

• The market size was approximately $930 million in 2022, with a CAGR of 6-8% expected through 2030.
• Major players include Mallinckrodt, with over 70% market share.
• Market growth depends on regulatory approvals, new indications, and pipeline activity.
• R&D costs remain high, and patent expiries could impact future revenues.
• Emerging applications and delivery technology improvements offer growth opportunities.

FAQs

1. What is nitric oxide used for in medicine?
Nitric oxide is primarily used to treat pulmonary hypertension, especially in neonatal and critical care, and to improve oxygenation in respiratory failure.

2. How does patent expiration affect the nitric oxide market?
Patent expiry, expected in the late 2020s for key products like INOmax, could lead to generic competition, potentially reducing prices and market share.

3. Are there significant new developments in nitric oxide therapies?
Research is ongoing in NO donors and alternative delivery methods for indications such as neuroprotection and wound healing, but broad clinical adoption remains limited.

4. Which regions are expanding their nitric oxide markets?
Asia-Pacific shows increasing demand due to expanding healthcare access and infrastructure, whereas North America remains the primary market.

5. What are the main obstacles to growth?
Technical challenges in delivery, limited pipeline activity, regulatory hurdles, and pricing constraints are primary obstacles.

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References

[1] MarketWatch. (2023). Nitric Oxide Drugs Market Size, Share & Industry Forecast.
[2] Grand View Research. (2022). Inhaled Nitric Oxide Market Size, Trends & Forecasts.
[3] FDA. (2023). Approval and Regulatory Information for INOmax.
[4] ClinicalTrials.gov. (2023). Ongoing Clinical Trials Investigating Nitric Oxide Applications.