INOMAX Drug Patent Profile

When do Inomax patents expire, and when can generic versions of Inomax launch?

Inomax is a drug marketed by Mallinckrodt Ireland and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fourteen patent family members in fifteen countries.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Inomax

Inomax was eligible for patent challenges on December 23, 2003.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INOMAX

International Patents:	114
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	15
Drug Prices:	Drug price information for INOMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INOMAX
What excipients (inactive ingredients) are in INOMAX?	INOMAX excipients list
DailyMed Link:	INOMAX at DailyMed

See drug prices for INOMAX

Recent Clinical Trials for INOMAX

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

Sponsor	Phase
Massachusetts General Hospital	N/A
University of California, Los Angeles	Phase 2
Mallinckrodt	Phase 2/Phase 3

See all INOMAX clinical trials

Pharmacology for INOMAX

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for INOMAX

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 INOMAX

INOMAX is protected by six US patents.

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	8,282,966*PED				Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,573,209*PED				Y
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	9,279,794*PED				Y

Expired US Patents for INOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,485,827*PED
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,873,359*PED
Mallinckrodt Ireland	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED

EU/EMA Drug Approvals for INOMAX

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 INOMAX

When does loss-of-exclusivity occur for INOMAX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

European Patent Office

Japan

Mexico

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INOMAX around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0754069
Australia	7440794
Germany	69534755

Supplementary Protection Certificates for INOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1516639	91404	Luxembourg		91404, EXPIRES: 20160801
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264	CA 2008 00019	Denmark

Market Dynamics and Financial Trajectory for INOMAX (Inhaled Nitric Oxide) Therapy

Last updated: July 27, 2025

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Introduction

INOMAX, a proprietary inhaled nitric oxide (iNO) therapy, plays a pivotal role in managing neonatal and adult pulmonary hypertension, as well as specific cardiac surgical procedures. Its unique mechanism of selectively vasodilating pulmonary vessels without systemic hypotension embeds it as an essential product within critical care settings. As medical paradigms shift with advances in respiratory and cardiovascular management, analyzing INOMAX's market landscape and financial trajectory becomes vital for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

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Market Landscape and Key Drivers

1. Growing Incidence of Pulmonary Hypertension

Pulmonary arterial hypertension (PAH) prevalence is rising globally due to increased awareness and diagnostic capabilities. Neonatal pulmonary hypertension remains a leading cause of morbidity and mortality in preterm and full-term infants. According to the World Health Organization, PAH affects approximately 15-50 per million adults globally, with neonatal cases significantly adding to the healthcare burden [1].

2. Critical Care and Neonatal Care Expansion

Technological advancements and improved neonatal intensive care units (NICUs) have enhanced survival rates for premature and critically ill patients, amplifying the demand for ventilatory and vasoregulatory products like INOMAX. The growing adoption of extracorporeal membrane oxygenation (ECMO) and advanced ventilatory strategies further support the need for inhaled vasodilators.

3. Regulatory Environment and Approvals

Until recently, INOMAX was primarily marketed by Pfizer, which withdrew the product from the U.S. market in 2021 citing strategic considerations [2]. However, alternative manufacturers have entered the space, seeking FDA approvals and market share. Regulatory pathways such as FDA's accelerated approval programs and reliance on existing safety data foster opportunities for new entrants.

4. Competitive Landscape and Patent Expiry

The original patent for INOMAX expired decades ago, exposing the market to generic and biosimilar entrants. Companies developing inhaled nitric oxide formulations or alternative pulmonary vasodilators influence market share dynamics. Furthermore, advancements in non-invasive ventilation technologies and novel PAH therapies could challenge INOMAX's growth niche.

5. Pricing, Reimbursement, and Cost-Effectiveness

The high cost associated with INOMAX therapy (~$2,000 per treatment course) and reimbursement variations significantly influence its utilization. The value-based care shift necessitates demonstration of cost-effectiveness, especially as more affordable alternatives develop.

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Financial Trajectory Analysis

1. Revenue Trends

Post-Pfizer's exit from the U.S. market, global revenues for INOMAX have faced pressures. Nonetheless, the emergence of new manufacturing companies and expanding markets in regions such as Asia-Pacific and Latin America present growth avenues. The global inhaled nitric oxide market was valued at USD 350 million in 2022 and projected to grow at a CAGR of 4-6% through 2030 [3].

2. Impact of Patent and Market Entry

The loss of patent exclusivity paired with generic availability dilutes pricing power and margins. However, niche positioning—focused on critically ill neonatal and adult patients—preserves a steady demand. Strategic partnerships, licensing agreements, and differentiation through delivery devices can influence financial outcomes.

3. Market Expansion Strategies

Investments in novel delivery mechanisms (e.g., portable nitric oxide generators) and research targeting new indications (e.g., COVID-19-related respiratory failure) can generate additional revenue streams. Moreover, regional market penetration, especially in emerging economies where NICU infrastructure grows, offers significant upside.

4. Cost and Manufacturing Considerations

Manufacturing costs for INOMAX vary with raw material prices, supply chain efficiency, and regulatory compliance. The implementation of scalable, cost-effective production processes and global supply networks can improve profit margins.

5. Future Outlook and Valuation

The future financial trajectory hinges on regulatory approvals, technological innovations, and competitive actions. Analysts forecast modest compound annual growth driven by expanding indications and geographic markets despite pricing pressures. A projected CAGR of approximately 3-5% over the next five years is plausible, contingent upon market access and reimbursement stability.

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Regulatory and Innovation Trends Impacting Market Dynamics

• Alternative Therapies: The development of new pulmonary vasodilators, such as phosphodiesterase inhibitors or prostacyclin analogs, provides competitive alternatives.
• Device Innovation: The integration of smarter delivery devices with real-time monitoring can enhance therapeutic efficacy and safety, impacting market share.
• Regulatory Landscape: Ongoing FDA approvals and global health policies advocating for critical care optimization shape the commercial environment.

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Conclusion

INOMAX's market dynamics are shaped by demographic shifts in pulmonary hypertension, technological innovation, and regulatory transformations. While its traditional market faces challenges from generic competition and alternative therapies, targeted expansion into emerging markets and innovation-driven differentiation maintain its relevance. Financially, the trajectory suggests steady growth, driven by increasing demand in neonatal and adult critical care, though margins are moderated by pricing pressures and generic ingress.

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Key Takeaways

• The increasing global prevalence of pulmonary hypertension and neonatal respiratory disorders sustains demand for INOMAX.
• Patent expiration and market entry of generics exert downward pressure on pricing and margins.
• Innovations in delivery technology and expanding indications (e.g., COVID-19) offer growth opportunities.
• Cost management and strategic regional expansion are key to maintaining financial performance.
• Regulatory landscape and reimbursement policies critically influence market access and profitability.

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FAQs

1. How has Pfizer's exit from the U.S. INOMAX market affected its global supply and pricing?
Pfizer's withdrawal in 2021 led to a supply gap in the U.S., prompting other manufacturers to fill the void. This disruption initially caused price fluctuations, but new entrants stabilized supply and gradually influenced pricing strategies based on manufacturing costs and market competition.

2. What are the primary competitors and alternatives to INOMAX?
Alternatives include other inhaled vasodilators such as prostacyclins, phosphodiesterase inhibitors like sildenafil, and non-pharmacologic approaches like advanced ventilation. The development of portable nitric oxide generators also paves the way for more accessible therapy.

3. Which emerging markets show the highest growth potential for INOMAX?
Regions such as China, India, and Latin America offer significant growth potential due to expanding healthcare infrastructure, increasing neonatal and critical care populations, and rising healthcare expenditure.

4. How might innovation in nitric oxide delivery devices impact the market?
Innovations like portable, user-friendly nitric oxide delivery systems can enhance therapeutic outcomes, reduce costs, and expand use cases, thereby heightening market growth prospects.

5. What is the outlook for new regulatory approvals related to INOMAX?
Regulatory authorities are increasingly receptive to innovative formulations and delivery systems. Pending approvals for new indications or improved devices could bolster market share and revenue streams.

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References

[1] World Health Organization. Pulmonary Hypertension: Global Epidemiology. 2021.
[2] Pfizer. Pfizer Announces Strategic Exit from US INOMAX Market. 2021.
[3] MarketResearch.com. Inhaled Nitric Oxide Market Size & Forecast. 2022.