INOMAX Drug Patent Profile

Which patents cover Inomax, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INOMAX

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					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
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

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
European Patent Office	0786264
Japan	7024013
Norway	943349
Japan	2011011059
Australia	2017201630	Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Germany	122008000012

Supplementary Protection Certificates for INOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1516639	300327	Netherlands		300327, 20111205, EXPIRES: 20160731
1516639	C300327	Netherlands		PRODUCT NAME: STIKSTOFMONOXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264	CA 2008 00019	Denmark
0786264	CR 2008 00019	Denmark		PRODUCT NAME: NITROGENOXID (NO); REG. NO/DATE: EU/1/01/194/001 20010801
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264	91423	Luxembourg		91423, EXPIRES: 20160801

Investment Scenario and Fundamentals Analysis for INOMAX

Last updated: February 20, 2026

What Are the Core Characteristics of INOMAX?

INOMAX (nitric oxide) is a pharmaceutical gas used primarily to treat neonates with hypoxic respiratory failure. It acts as a selective pulmonary vasodilator, reducing pulmonary hypertension and improving oxygenation. INOMAX is marketed by Pfizer and its licensing history includes approval by the FDA in 1999. It is administered via inhalation in medical settings.

Product Status and Market Data

Parameter	Details
Product Name	INOMAX (nitric oxide)
Manufacturer	Pfizer
FDA Approval Date	1999
Indication	Neonatal hypoxic respiratory failure
Route of Administration	Inhalation
Patent Status	Patent expired in 2012 (market exclusivity ended)
Market Revenue (2021)	Estimated $350 million (globally)
Major Markets	US, Europe, Japan

What Are the Key Drivers of INOMAX’s Investment Outlook?

Market Fundamentals

• Niche Use and Market Size: INOMAX’s role in neonatal intensive care limits its market to specialized hospitals. The global neonatal respiratory care market was valued at roughly $3.4 billion in 2021, with INOMAX accounting for a fraction.
• Growth Trends: The neonatal respiratory market is growing at approximately 4% annually, driven by increasing birth rates in emerging markets and advanced neonatal care protocols.
• Reimbursement Policies: INOMAX benefits from favorable reimbursement policies in key markets like the US, where neonatal medications are well-covered, supporting continued usage.

Competitive Landscape

• Patent Expiry and Generics: The original patent expired in 2012; generic versions have since entered the market, pressuring prices and margins.
• Alternative Therapies: Emerging treatments for pulmonary hypertension, including inhaled prostacyclins and phosphodiesterase inhibitors, pose competition.

Regulatory Environment and Pricing

• FDA and Regulatory Posture: INOMAX remains FDA-approved; however, regulatory agencies emphasize cost-effective neonatal treatments, influencing pricing strategies.
• Pricing Trends: The average wholesale price (AWP) for INOMAX has declined from approximately $100 per dose in 2010 to around $60 in 2021, pressured by generics.

R&D and Pipeline Considerations

• Innovative Delivery: Pfizer has invested in development of portable and aerosolized delivery systems, potentially enhancing user convenience.
• Pipeline Status: No significant pipeline candidates specific to nitric oxide are publicly disclosed; focus remains on maintaining existing formulations and delivery methods.

What Are the Investment Risks and Opportunities?

Risks

• Market Saturation: Loss of exclusivity and entry of generics diminish revenue.
• Pricing Pressure: Reimbursement constraints and competing therapies reduce pricing power.
• Regulatory Challenges: Future safety or efficacy concerns could lead to restrictions or label updates.
• R&D Limitations: Absence of pipeline innovations limits growth prospects.

Opportunities

• Market Expansion: Increasing neonatal care in emerging markets offers new sales channels.
• Product Differentiation: Development of advanced delivery systems improves clinical utility.
• Broadening Indications: Potential expanded use for pulmonary hypertension in adult or pediatric populations.

How Do Financials Support Investment Decisions?

Pfizer’s sales of INOMAX have stabilized at approximately $350 million annually, indicating a mature product phase. Operating margins are pressured by generic competition, with net margins in the core neonatal segment potentially declining. Investment suitability depends on Pfizer’s strategic focus on neonatal care and pipeline innovation.

What Are Strategic Considerations for Investors?

• Market Penetration in Emerging Markets: Targeting new neonatal units.
• Lifecycle Management: Engaging in new formulations or delivery devices.
• Partnerships: Collaborations with biotech firms for pipeline expansion.
• Cost Management: Improving manufacturing efficiencies amid price pressures.

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Key Takeaways

• INOMAX is a niche, well-established neonatal respiratory drug, with annual revenues around $350 million.
• Patent expiration in 2012 paved the way for generic competition, diminishing margins.
• Market growth is driven by neonatal care demand, especially in emerging regions.
• Competitive pressures from alternative therapies and reimbursement policies pose risks.
• Innovation in delivery systems and market expansion remain untapped growth avenues.

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FAQs

1. How does patent expirations impact INOMAX’s pricing?
Patent expiration in 2012 allowed generics to enter, lowering prices and reducing Pfizer’s market share.

2. What is the current size of the market for neonatal nitric oxide therapies?
Globally, it is estimated at over $3 billion, with INOMAX holding a significant but declining share.

3. Are there recent regulatory changes affecting INOMAX?
No recent major regulatory updates; however, ongoing reimbursement and safety evaluations influence market dynamics.

4. What competitive therapies threaten INOMAX’s market position?
Inhaled prostacyclins, phosphodiesterase inhibitors, and new pulmonary hypertension treatments are considered competitors.

5. What growth strategies can Pfizer pursue for INOMAX?
Expanding in emerging markets, developing improved delivery devices, and exploring new indications are potential strategies.

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References

[1] Pfizer. (2021). INOMAX product information.
[2] MarketWatch. (2022). Neonatal respiratory therapy market size & trends.
[3] FDA. (1999). INOMAX approval documents.
[4] IQVIA. (2022). Global neonatal respiratory drug sales data.
[5] Global Market Insights. (2022). Pulmonary hypertension therapeutics market forecast.