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 Hosp, 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-two 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:	172
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:	1,008
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
University Hospital, Rouen	Phase 3
VA Eastern Colorado Health Care System	Phase 2
VA Boston Healthcare System	Phase 2

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
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	11,511,252		Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	8,607,785		Y
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	9,604,028
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	11,291,793		Y

Expired US Patents for NITRIC OXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	6,758,214
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	6,125,846*PED
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,732,693*PED

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/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 NITRIC OXIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2012502770
Australia	2017204422	Gas delivery device and system
Mexico	2019003564	APARATO Y METODO PARA MONITORIZAR EL SUMINISTRO DE OXIDO NITRICO. (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY.)
European Patent Office	2269614	Procédé d'identification d'une population de patients éligibles au traitement au monoxyde d'azote (A method of identifying a patient population suited to receiving nitric oxide)

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

NITRIC OXIDE Market Analysis and Financial Projection Experimental

Nitric Oxide Drugs & Therapeutics Market: Dynamics and Financial Trajectory

Market Overview

Nitric oxide, a colorless, tasteless, and short-acting gas, plays a crucial role in various physiological processes, including the widening of blood vessels in the lungs when inhaled. It is a key signaling molecule in the cardiovascular, immune, and central nervous systems. Here’s a detailed look at the market dynamics and financial trajectory of nitric oxide drugs and therapeutics.

Market Size and Growth

The global nitric oxide drugs and therapeutics market is projected to reach $5.03 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 3.8% during the forecast period from 2023 to 2029. In 2022, the market size was approximately $3.87 billion[1].

Market Drivers

Several factors are driving the growth of the nitric oxide drugs and therapeutics market:

Rising Prevalence of Diseases

The increasing prevalence of neural disorders, respiratory disorders, and cardiovascular diseases is a significant driver. Specifically, the rise in patients with chronic obstructive pulmonary disease (COPD) and acute respiratory diseases boosts the demand for nitric oxide treatments[1].

Experimental Use in COVID-19

Nitric oxide's antiviral properties and its ability to improve oxygenation have led to its experimental use in treating COVID-19, particularly for frontline workers. This has further accelerated market growth[1].

Growing Patient Awareness and Geriatric Population

Increasing patient awareness and a growing geriatric population contribute to the market's expansion. The elderly are more prone to chronic diseases, which in turn increases the demand for nitric oxide-based therapies[1].

Research and Development

Ongoing clinical trials, technological advancements, and new product launches are creating potential opportunities for market growth. For instance, Mallinckrodt has initiated a retrospective study on the use of inhaled nitric oxide in COVID-19 patients[1].

Market Segmentation

The global nitric oxide drugs and therapeutics market is segmented based on drug type, therapy, application, and end-users.

Drug Type

The market includes inorganic drugs, donating drugs, hybrid drugs, and others. Each type has its specific applications and market share[1].

Therapy

Inhalation therapy is expected to grow rapidly during the forecast period, with a CAGR of 7.9%. This growth is driven by the increasing prevalence of respiratory disorders and the current experimental use of nitric oxide in treating COVID-19[1].

Application

Nitric oxide is used in various applications, including inflammatory disorders, cardiovascular diseases, erectile dysfunction, and neuroprotection. The versatility of nitric oxide in treating different conditions contributes to its market growth[1].

End-Users

The market is segmented into diagnostic laboratories, pathology labs, and research labs. These end-users drive the demand for nitric oxide-based products and therapies[1].

Regional Analysis

North America

North America is expected to dominate the global market during the forecast period. The region is home to many commercial developments of nitric oxide-based products, with the USA and Europe being prominent players due to favorable government policies and increased funding for research activities[1].

Europe

Europe follows North America in terms of market share. The widespread application of nitric oxide in health and disease, along with regulatory approvals, positions Europe as a significant market[1].

Asia-Pacific (APAC)

The APAC region is expected to be the fastest-growing market. Rising awareness among patients, increasing healthcare expenditure, and the prevalence of respiratory and cardiovascular disorders are key factors driving market growth in this region[1].

Benefits of Inhaled Nitric Oxide

Inhaled nitric oxide (INO) is gaining traction due to several benefits:

Minimally Invasive Therapy

INO is preferred for its minimally invasive nature, which reduces systemic adverse reactions and offers rapid offset of action. This makes it safer and more effective compared to other medications[4].

Reduced Dosage

The use of reduced doses of INO compared to other medications is another advantage. This reduces the risk of adverse effects and improves patient compliance[4].

Side Effects and Safety

While nitric oxide is effective, it can cause several side effects:

Common Side Effects

These include blurred vision, confusion, dizziness, faintness, lightheadedness, sweating, and unusual tiredness or weakness[5].

Serious Side Effects

More severe side effects such as bluish lips or skin, chest discomfort, difficult or labored breathing, and tightness in the chest require immediate medical attention[5].

Clinical Trials and Research

Nitric oxide is under extensive research, with numerous clinical trials ongoing:

Phase Trials

The drug is in various stages of clinical trials, including Phase 0, Phase 1, Phase 2, Phase 3, and Phase 4 trials. These trials are crucial for understanding its efficacy and safety in different applications[2].

Key Players and Products

Several companies are involved in the development and marketing of nitric oxide-based products:

Ino Therapeutics

Ino Therapeutics is a key player, with products like Inomax and Genosyl Gas. These products are approved and widely used in various regions[2].

Financial Outlook

The financial trajectory of the nitric oxide drugs and therapeutics market is positive, driven by increasing demand and advancements in technology.

Market Forecast

The market is expected to grow significantly, reaching $5.03 billion by 2029. This growth is supported by the rising adoption of inhaled nitric oxide as a minimally invasive therapy and the expanding use of nitric oxide in treating various diseases[1].

Conclusion

The nitric oxide drugs and therapeutics market is poised for significant growth, driven by the rising prevalence of chronic diseases, increasing patient awareness, and ongoing research activities. The benefits of inhaled nitric oxide, including its minimally invasive nature and reduced dosage, further support its market expansion.

Key Takeaways

• The global nitric oxide drugs and therapeutics market is projected to reach $5.03 billion by 2029.
• The market is driven by the rising prevalence of neural, respiratory, and cardiovascular disorders.
• Inhaled nitric oxide is gaining traction due to its minimally invasive nature and reduced dosage.
• North America and Europe are dominant regions, with APAC expected to be the fastest-growing market.
• Ongoing clinical trials and technological advancements are creating potential opportunities for market growth.

FAQs

What is the primary use of nitric oxide in medical treatments?

Nitric oxide is primarily used to treat hypoxic respiratory failure in premature neonates and is also used in various other applications such as inflammatory disorders, cardiovascular diseases, and erectile dysfunction[2].

What are the benefits of inhaled nitric oxide?

Inhaled nitric oxide is preferred for its minimally invasive nature, reduced systemic adverse reactions, rapid offset of action, and improved efficacy and safety compared to other medications[4].

Which regions are expected to dominate the nitric oxide drugs and therapeutics market?

North America is expected to dominate the market, followed by Europe, with the Asia-Pacific region being the fastest-growing market[1].

What are the common side effects of nitric oxide treatment?

Common side effects include blurred vision, confusion, dizziness, faintness, lightheadedness, sweating, and unusual tiredness or weakness[5].

What is the current market size and projected growth of the nitric oxide drugs and therapeutics market?

The current market size is approximately $3.87 billion, and it is projected to reach $5.03 billion by 2029, growing at a CAGR of 3.8%[1].

Sources

1. Maximize Market Research: Nitric Oxide Drugs & Therapeutics Market - Forecast (2023-2029)
2. DrugBank: Nitric Oxide: Uses, Interactions, Mechanism of Action
3. Market Research Intellect: Global Inhaled Nitric Oxide Delivery Device Market Size, Trends and ...
4. BioSpace: Inhaled Nitric Oxide Delivery Systems Market Insights, 2031
5. Mayo Clinic: Nitric oxide (inhalation route) - Mayo Clinic