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Nitric oxide - Generic Drug Details

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What are the generic drug sources for nitric oxide and what is the scope of nitric oxide patent protection?

Nitric oxide is the generic ingredient in two branded drugs marketed by Mallinckrodt Hosp and Praxair Distribution, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nitric oxide has sixty-two patent family members in thirteen countries.

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

Summary for nitric oxide

International Patents:	62
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Suppliers / Packagers:	2
Bulk Api Vendors:	11
Clinical Trials:	764
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nitric oxide
DailyMed Link:	nitric oxide at DailyMed

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

Synonyms for nitric oxide

(.)NO

(NO)(.)

[NO]

10102-43-9

31C4KY9ESH

AC1L3QHF

C00533

CHEBI:16480

CHEMBL1200689

CTK0H7679

D00074

D0A5FM

D0W2BD

DB00435

DTXSID1020938

EDRF

Endogenous Nitrate Vasodilator

Endothelium-Derived Nitric Oxide

endothelium-derived relaxing factor

Endothelium-derived relaxing factor (EDRF)

INOmax

INOmax (TN)

Mononitrogen monoxide

Monoxide, Mononitrogen

Monoxide, Nitrogen

monoxido de nitrogeno

monoxyde d'azote

Nitrate Vasodilator, Endogenous

Nitric oxide (JAN)

Nitric oxide trimer

Nitric oxide, 98.5%

Nitric Oxide, Endothelium Derived

Nitric Oxide, Endothelium-Derived

NITRIC-OXIDE

nitrogen monooxide

nitrogen monoxide

nitrogen protoxide

Nitrogen(II) oxide

Nitrosoradical

nitrosyl

Nitrosyl radical

Nitroxide radical

NO(.)

NO()

OHM 11771

Oxide, Nitric

oxido de nitrogeno(II)

oxido nitrico

oxidonitrogen(.)

Oxidonitrogen()

oxoazanyl

oxyde azotique

Stickstoff(II)-oxid

Stickstoffmonoxid

Vasodilator, Endogenous Nitrate

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	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes
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	020845-002	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999

International Patents for nitric oxide

Country	Document Number	Estimated Expiration
European Patent Office	2269614
Canada	2905644
European Patent Office	2968824
Japan	2011011059
World Intellectual Property Organization (WIPO)	2014159912

Supplementary Protection Certificates for nitric oxide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB08/019	United Kingdom		PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
02C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801