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Last Updated: December 10, 2023

Nitric oxide - Generic Drug Details

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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 thirty-nine 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 sixty-seven 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:	167
US Patents:	39
Tradenames:	4
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	996
Formulation / Manufacturing:	see details
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
Ain Shams University	Phase 3
University of Alabama at Birmingham	Early Phase 1
Wake Forest University Health Sciences	Phase 1

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for nitric oxide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	⤷ Try a Trial	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	⤷ Try a Trial	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	⤷ Try a Trial	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	⤷ Try a Trial	⤷ Try a Trial
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	⤷ Try a Trial	⤷ Try a Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for nitric oxide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for nitric oxide

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Country	Patent Number	Title	Estimated Expiration
Japan	5950965		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2010033916		⤷ Try a Trial
Canada	3114977	APPAREIL ET PROCEDE POUR LA SURVEILLANCE DE L'ADMINISTRATION D'OXYDE NITRIQUE (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY)	⤷ Try a Trial
Poland	2968824		⤷ Try a Trial
Australia	2014244334	Apparatus and method for monitoring nitric oxide delivery	⤷ Try a Trial
Canada	2965159	CASSETTE DE STOCKAGE DE DIOXYDE D'AZOTE (NITROGEN DIOXIDE STORAGE CASSETTE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for nitric oxide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0786264	SPC/GB08/019	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium	⤷ Try a Trial	PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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