Nitric oxide - Generic Drug Details

What are the generic sources for nitric oxide and what is the scope of freedom to operate?

Nitric oxide is the generic ingredient in three branded drugs marketed by Vero Biotech, Mallinckrodt Hosp, and Linde Gas Equip, and is included in three NDAs. There are thirty-seven 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 fifty-four patent family members in fifteen countries.

There are six drug master file entries for nitric oxide. Three suppliers are listed for this compound.

Summary for nitric oxide

International Patents:	154
US Patents:	37
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	968
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
Simon Fraser University	Phase 2
Medical College of Wisconsin	Early Phase 1
Massachusetts General Hospital	Early 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

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
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Linde Gas Equip	NOXIVENT	nitric oxide	GAS;INHALATION	207141-002	Oct 2, 2018	AA	RX	No	No
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Vero Biotech	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes			Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					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	020845-003	Dec 23, 1999
Vero Biotech	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999

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	2022078116	二酸化窒素貯蔵カセット (NITROGEN DIOXIDE STORAGE CASSETTE)
Denmark	3308820
Mexico	2014005524	APARATO Y METODO PARA VIGILAR EL SUMINISTRO DE OXIDO NITRICO. (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY.)
Australia	2019253886	SYSTEMS AND METHODS FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE
Canada	2939094	PROCEDES POUR COMPENSER UNE DERIVE DE SENSIBILITE A LONG TERME DE CAPTEURS DE GAZ ELECTROCHIMIQUES EXPOSES A DE L'OXYDE NITRIQUE (METHODS FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE)

Supplementary Protection Certificates for nitric oxide

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
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801