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 forty-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:	41
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	1,102
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	020845-004	Jan 17, 2023		RX	Yes	Yes			Y	Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes
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	020845-002	Dec 23, 1999
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

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
Australia	2015202618
Mexico	2019003564	APARATO Y METODO PARA MONITORIZAR EL SUMINISTRO DE OXIDO NITRICO. (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY.)
New Zealand	611564	Gas delivery device and system

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 the Pharmaceutical Drug: Nitric Oxide

Last updated: July 27, 2025

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Introduction

Nitric oxide (NO), a versatile gaseous signaling molecule, has emerged as a promising pharmaceutical agent with extensive therapeutic applications. Its ability to induce vasodilation, modulate immune responses, and influence cellular signaling pathways has propelled research and development efforts across various medical fields. As the global demand for innovative treatments surges, understanding the market dynamics and financial trajectory of nitric oxide-based therapeutics becomes essential for stakeholders, including pharmaceutical companies, investors, and healthcare policymakers.

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Market Overview

The nitric oxide therapeutics market is characterized by rapid innovation, driven by expanding clinical indications, technological advancements, and regulatory support. Historically, NO’s primary use has been in neonatal care for persistent pulmonary hypertension of the newborn (PPHN), where inhaled nitric oxide (iNO) has been standard. However, recent research expands its potential into cardiovascular diseases, pulmonary hypertension, neurodegenerative disorders, wound healing, and oncology.

According to a report by Grand View Research, the global nitric oxide therapeutics market was valued at approximately USD 500 million in 2021 and is projected to grow at a compounded annual growth rate (CAGR) of over 8% through 2030 [1]. The growth trajectory reflects both increasing clinical applications and technological advancements in delivery mechanisms.

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Key Market Drivers

1. Expanding Clinical Indications

   • Pulmonary Hypertension: iNO remains a frontline therapy in neonatal and adult pulmonary hypertension, with ongoing trials exploring its use in COVID-19-related respiratory complications, emphasizing its relevance in acute respiratory distress syndrome (ARDS) [2].

   • Cardiovascular Diseases: NO’s vasodilatory properties support its use in acute myocardial infarction, heart failure, and peripheral artery disease, fostering new formulations and delivery systems.

   • Neurodegenerative and Wound Therapy: Emerging evidence suggests NO’s role in neuroprotection and wound healing, prompting pipeline products targeting these conditions.

2. Technological Innovation

   • Novel Delivery Systems: Development of stable, controlled-release NO donors and inhalation devices enhances therapeutic efficacy and patient compliance.

   • Combination Therapies: Integration of nitric oxide donors with other drugs enhances synergistic effects, broadening application spectrum.

3. Regulatory and Reimbursement Support

   • Regulatory agencies such as the FDA and EMA have approved several NO-based formulations, bolstering market confidence. Reimbursement policies favor adoption in neonatal intensive care units (NICUs) and specialized pulmonary centers.

4. Rising Prevalence of Target Diseases

   • The global burden of pulmonary hypertension, cardiovascular diseases, and COVID-19 infections fuels demand for effective therapies, including NO.

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Market Challenges

• Safety Concerns: Potential risks include methemoglobinemia, nitrogen dioxide (NO₂) toxicity, and oxidative stress, which necessitate rigorous safety evaluation.

• Delivery and Stability Issues: NO's gaseous nature complicates storage, transport, and controlled delivery, impacting commercialization.

• Pricing and Reimbursement: High manufacturing costs and limited reimbursement in certain regions hinder widespread adoption, particularly for emerging indications.

• Competition from Alternatives: Emerging therapies, such as phosphodiesterase inhibitors and other vasodilators, pose competitive challenges.

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Financial Trajectory and Investment Trends

Over recent years, investment into nitric oxide therapeutics has increased markedly. Venture capital funding and large pharmaceutical R&D budgets target innovative NO delivery platforms and expanded indications. Notably:

• Market Penetration: Established products like INOmax (for neonatal PPHN) generate significant revenue, with sales reaching USD 250 million annually before patent expiry considerations [3].

• Pipeline Expansion: Several biotech firms are advancing NO donor compounds, inhalation devices, and combination products to address unmet needs.

• Mergers and Acquisitions: Larger pharmaceutical companies are acquiring smaller innovators to secure proprietary delivery technologies and access new revenue streams.

Analysts forecast that innovative NO-based therapies could achieve revenues exceeding USD 1 billion by 2030, contingent on regulatory approvals and commercial scalability [1].

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Regulatory Landscape

Approval pathways remain streamlined for inhaled nitric oxide in neonatal and pulmonary indications. However, expanding into systemic or chronic applications requires comprehensive safety and efficacy data. Regulatory agencies emphasize standardized manufacturing practices, dose control, and safety monitoring mechanisms, which influence time-to-market and cost structures.

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Market Segments and Regional Insights

• Geographic Distribution: North America dominates due to advanced healthcare infrastructure, high research investment, and early adoption. Asia-Pacific exhibits growth potential driven by rising disease prevalence and emerging markets’ healthcare expansion.

• Segment Focus: Critical care inhaled NO constitutes the largest segment, followed by novel NO donors for systemic use, topical applications in wound care, and investigational gene therapy related to NO pathways.

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Future Opportunities

• Personalized Medicine: Tailoring NO therapies based on genetic, physiological, or disease-specific biomarkers could enhance therapeutic outcomes and market penetration.

• Digital and Smart Delivery Devices: Incorporation of IoT-enabled inhalers and real-time monitoring enhances patient safety and adherence.

• Combination Therapies: Co-administration with other modalities such as antioxidants or anti-inflammatory agents presents new growth avenues.

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Key Market Players

Leading firms include Air Liquide Healthcare, Mallinckrodt Pharmaceuticals, Ikaria Inc., and Modus Therapeutics. Innovation pipelines are bolstered by startups and biotech firms like NISI and Creo Medical, focusing on next-generation NO delivery systems and novel indications.

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Conclusion

The nitric oxide therapeutics market stands at a dynamic intersection of technological innovation, expanding clinical applications, and growing disease burden. While challenges persist—particularly regarding safety, stability, and reimbursement—ongoing research and favorable regulatory frameworks underpin a robust financial trajectory. Strategic investments in technological advancements and pipeline development are poised to unlock significant value, positioning nitric oxide-based therapies as integral components of future medical practice.

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Key Takeaways

• The nitric oxide therapeutics market is poised for robust growth, driven by expanding indications and technological innovation, with an estimated CAGR exceeding 8% through 2030.
• Innovations in delivery mechanisms and combination therapies will be pivotal in overcoming current clinical and logistical challenges.
• Regulatory support and rising disease prevalence, especially pulmonary hypertension and COVID-19-related complications, underpin market expansion.
• Major players benefit from established products like INOmax, but pipeline entrants and startups are shaping future growth.
• Strategic focus on personalized medicine and smart delivery platforms can enhance market penetration and ROI.

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FAQs

1. What are the primary medical indications for nitric oxide pharmaceuticals?
Nitric oxide is widely used in neonatal pulmonary hypertension, adult pulmonary hypertension, cardiovascular conditions such as myocardial infarction, and increasingly in respiratory illnesses like ARDS, including COVID-19 related cases.

2. What challenges hinder the widespread adoption of nitric oxide therapies?
Key hurdles include safety concerns (methemoglobinemia, NO₂ toxicity), delivery stability issues, high manufacturing costs, and reimbursement limitations in certain regions.

3. How does technological innovation influence the nitric oxide market?
Advances in controlled-release formulations, inhalation devices, and combination therapies improve efficacy, safety, and patient adherence, thus expanding market opportunities.

4. What is the financial outlook for nitric oxide-based pharmaceuticals?
Projections suggest revenues surpassing USD 1 billion by 2030, driven by pipeline expansion, market penetration, and strategic partnerships among key players.

5. Which regions are leading in the nitric oxide therapeutic market?
North America leads due to early adoption and extensive healthcare infrastructure, while Asia-Pacific offers significant growth potential owing to rising disease prevalence and healthcare development.

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References

[1] Grand View Research. "Nitric Oxide Therapeutics Market Size, Share & Trends Analysis Report." 2022.
[2] Zhang, H., et al. "The role of inhaled nitric oxide in COVID-19 therapy." Critical Care, 2021.
[3] U.S. Food and Drug Administration. "INOMAX (inhaled nitric oxide) approvals and regulatory information." 2022.