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INOMAX Drug Patent Profile

When do Inomax patents expire, and what generic alternatives are available?

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

This drug has one hundred and twelve 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 five 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:	112
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
Versiti	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 Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,282,966*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,573,209*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	9,279,794*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,795,741*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	8,431,163*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,291,904*PED				Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	8,573,210*PED				Y

Expired US Patents for INOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,873,359*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	6,125,846*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,485,827*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,732,693*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,752,504*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	6,125,846*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/000337 INOmax, 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
Japan	3510755
Luxembourg	90886
Japan	7024013
Japan	2020044373	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)
Austria	376850
Norway	310961
Australia	2018205119	Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension

Supplementary Protection Certificates for INOMAX

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
1516639	C300327	Netherlands		PRODUCT NAME: STIKSTOFMONOXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
1516639	07C0080	France		PRODUCT NAME: MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0560928	SPC/GB02/009	United Kingdom
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
1516639	C01516639/01	Switzerland		PRODUCT NAME: NITROGENII OXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56809 09.07.2004
1516639	91404	Luxembourg		91404, EXPIRES: 20160801

INOMAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INOMAX

Introduction

INOmax, a brand of inhaled nitric oxide gas, has been a significant player in the medical field for over two decades, particularly in the treatment of respiratory conditions. Here, we will delve into the market dynamics and financial trajectory of INOMAX, highlighting its current status, future prospects, and the broader market context.

Historical Context and Efficacy

INOmax has a well-established efficacy and safety profile, with over 20 years on the market and more than 875,000 patients treated globally. This long-standing presence has solidified its position as a reliable treatment option for various respiratory conditions[1].

Market Size and Growth

The global inhaled nitric oxide delivery systems market, in which INOMAX operates, was valued at USD 345.1 million in 2023. This market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2024 to 2030. The growth is driven by increasing prevalence of respiratory diseases such as chronic obstructive pulmonary disease (COPD) and neonatal respiratory distress syndrome (RDS)[4].

Key Market Segments

Patient Segments

The market is segmented into neonatal and adult patient groups. The neonatal segment, particularly for conditions like Hypoxic Respiratory Failure (HRF) and Persistent Pulmonary Hypertension of the Newborn (PPHN), has been a dominant area for INOMAX due to its efficacy in improving oxygenation and reducing the need for invasive treatments like Extracorporeal Membrane Oxygenation (ECMO)[4].

The adult segment, including conditions such as Acute Respiratory Distress Syndrome (ARDS) and COPD, is also growing, driven by increasing awareness and ongoing clinical trials exploring the efficacy of inhaled nitric oxide therapy in these conditions[4].

Product Segments

The disposables segment, which includes items like delivery masks, tubing, and cartridges, holds the largest revenue share due to high usage frequency and the necessity for single-use components to ensure patient safety and prevent cross-contamination[4].

The system segment, which includes the delivery systems themselves, is projected to grow steadily as modern systems become more compact, user-friendly, and integrated with advanced features like real-time monitoring and automated dosage adjustments[4].

Healthcare Settings

Hospitals dominate the market with an 80.2% revenue share, due to their advanced medical infrastructure and the high volume of patients requiring critical care. However, ambulatory centers are expected to grow at the fastest rate, driven by the shift towards outpatient care and the demand for cost-effective and convenient treatment options[4].

Financial Performance of Mallinckrodt

Mallinckrodt plc, the company behind INOMAX, has reported mixed financial results in recent years.

Revenue and Net Sales

In fiscal 2023, Mallinckrodt reported net sales of $243.0 million for the fourth quarter and $489.3 million for the full year. These figures indicate a slight increase compared to the previous year, with the company exceeding its annual net sales guidance[3].

Cost and Expenses

The cost of sales remains high, at 73.7% of net sales for the fourth quarter of 2023, which impacts the gross profit margin. Selling, general, and administrative expenses, as well as research and development expenses, also contribute to the operating loss. However, the company has been working to manage these costs and improve its financial health[3].

Operating Loss and Net Income

Despite the revenue growth, Mallinckrodt reported an operating loss of $20.2 million for the fourth quarter of 2023 and a net loss of $38.2 million. However, the company's financial performance can be volatile due to reorganization items and other factors, as seen in the significant net income of $1,090.6 million in the previous year, largely due to reorganization items[3].

Future Prospects and Guidance

Mallinckrodt is optimistic about the future, particularly with the FDA clearance of the INOmax EVOLVE system, which is expected to enhance the delivery and administration of inhaled nitric oxide therapy[1].

Marketing and Adoption

The company plans to continue investing in marketing for its products, including Terlivaz, to drive hospital adoption and early patient identification. This strategic focus is expected to boost sales and market penetration[2].

Market Expansion

The growing demand for inhaled nitric oxide therapy, especially in ambulatory centers and home care settings, presents opportunities for market expansion. Advances in medical technology and the development of more portable and user-friendly delivery systems will further drive this growth[4].

Regional Market Dynamics

North America, particularly the U.S., holds a significant share of the global inhaled nitric oxide delivery systems market, driven by advanced healthcare infrastructure, substantial healthcare expenditure, and a strong focus on research and development[4].

Key Takeaways

• Established Efficacy: INOMAX has a well-established efficacy and safety profile with over 20 years on the market.
• Market Growth: The global inhaled nitric oxide delivery systems market is expected to grow at a CAGR of 4.5% from 2024 to 2030.
• Segment Dominance: The neonatal segment and disposables segment are currently dominant, but the adult segment and ambulatory centers are expected to grow significantly.
• Financial Performance: Mallinckrodt has reported mixed financial results but is optimistic about future growth driven by marketing efforts and technological advancements.
• Regional Focus: North America, especially the U.S., is a key market due to its advanced healthcare infrastructure and significant healthcare expenditure.

FAQs

What is INOMAX used for?

INOmax is used for the treatment of various respiratory conditions, including Hypoxic Respiratory Failure (HRF), Persistent Pulmonary Hypertension of the Newborn (PPHN), and Acute Respiratory Distress Syndrome (ARDS).

How long has INOMAX been on the market?

INOmax has been on the market for over 20 years, with more than 875,000 patients treated globally.

What is the projected growth rate of the inhaled nitric oxide delivery systems market?

The global inhaled nitric oxide delivery systems market is anticipated to grow at a CAGR of 4.5% from 2024 to 2030.

Which segment dominates the inhaled nitric oxide delivery systems market?

The hospitals segment currently dominates the market, but the ambulatory centers segment is expected to grow at the fastest rate over the forecast period.

What are the key drivers of the inhaled nitric oxide delivery systems market?

The key drivers include the increasing prevalence of respiratory diseases, advancements in medical technology, and the rising demand for cost-effective and convenient treatment options.

Sources

1. Mallinckrodt Announces FDA Clearance of the INOmax ® EVOLVE ... - Mallinckrodt.
2. Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 ... - Stock Titan.
3. Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 ... - PR Newswire.
4. Inhaled Nitric Oxide Delivery Systems Market Size Report, 2030 - Grand View Research.