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 three branded drugs marketed by Vero Biotech, Mallinckrodt Hosp, and Linde Gas Equip, and is included in three NDAs. There are thirty-five 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 forty-eight patent family members in fifteen countries.

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

Summary for nitric oxide

International Patents:	148
US Patents:	35
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	952
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
The University of Texas Health Science Center, Houston	Phase 4
Josef Stehlik	Phase 4
Merck Sharp & Dohme LLC	Phase 4

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	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
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					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
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999
Vero Biotech	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019

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
Portugal	2968824
European Patent Office	2540304	Procédés pour réduire le risque ou prévenir l'apparition d'un événement défavorable ou d'un événement défavorable grave associés au traitement par oxyde nitrique inhalé (Methods for reducing the risk or preventing the occurrence of an adverse event or serious adverse event associated with the inhalation of nitric oxide treatment)
European Patent Office	2131903	CONVERSION DU DIOXYDE D'AZOTE (NO2) EN OXYDE NITRIQUE (NO) (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO))
China	110501462	用于补偿暴露于一氧化氮的电化学气体传感器的长期灵敏度漂移的方法 (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