Nitric oxide - Generic Drug Details

✉ Email this page to a colleague

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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Subscribe
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	8,057,742	⤷ Subscribe				⤷ Subscribe
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	8,226,916	⤷ Subscribe				⤷ Subscribe
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	7,947,227	⤷ Subscribe				⤷ Subscribe
Linde Gas Equip	NOXIVENT	nitric oxide	GAS;INHALATION	207141-002	Oct 2, 2018	AA	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	10,814,092	⤷ Subscribe				⤷ Subscribe
>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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vero Biotech Inc	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019	6,758,214	⤷ Subscribe
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,485,827*PED	⤷ Subscribe
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	5,752,504*PED	⤷ Subscribe
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	6,125,846*PED	⤷ Subscribe
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	5,558,083*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for nitric oxide

Subscribe to access the full database, or Subscribe
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

Subscribe to access the full database, or Subscribe
Country	Patent Number	Title	Estimated Expiration
Japan	2022101594	一酸化窒素に曝される電気化学ガスセンサーの長期の感度変動を補償する方法	⤷ Subscribe
Japan	2019013763	一酸化窒素の送達を監視するための器具および方法 (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY)	⤷ Subscribe
Japan	2015013118	二酸化窒素（ＮＯ２）から酸化窒素（ＮＯ）への変換 (CONVERSION OF NITROGEN DIOXIDE (NO2) TO NITRIC OXIDE (NO))	⤷ Subscribe
Brazil	112013017498	dispositivo e sistema de distribuição de gás	⤷ Subscribe
Japan	2014532523	一酸化窒素送出を監視する装置および方法	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for nitric oxide

Subscribe to access the full database, or Subscribe
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0786264	SPC/GB08/019	United Kingdom	⤷ Subscribe	PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium	⤷ Subscribe	PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.