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 three branded drugs marketed by Vero Biotech, Mallinckrodt Hosp, and Praxair Distribution, and is included in three 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 eighty-two 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:	82
US Patents:	15
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	6
Suppliers / Packagers:	3
Bulk Api Vendors:	12
Clinical Trials:	823
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nitric oxide
DailyMed Link:	nitric oxide at DailyMed

Recent Clinical Trials for nitric oxide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Joshua Korzenik	Phase 2
Lund University	Phase 4
ALK-Abelló A/S	Phase 4

See all nitric oxide clinical trials

Recent Litigation for nitric oxide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc.	2016-07-08
Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc.	2015-02-19

See all nitric oxide litigation

PTAB Litigation

Petitioner	Date
	2016-03-23
	2015-03-16
	2015-01-05

See all nitric oxide litigation

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
C00533
CHEBI:16480
CHEMBL1200689
CTK0H7679
D00074
DB00435
DTXSID1020938
EDRF
endothelium-derived relaxing factor
HOA
INOmax (TN)
Mononitrogen monoxide
monoxido de nitrogeno
monoxyde d'azote
Nitric oxide (JAN)
Nitric oxide, 98.5%
nitrogen monooxide
nitrogen monoxide
Nitrosoradical
nitrosyl
NO(.)
OHM 11771
oxido de nitrogeno(II)
oxido nitrico
oxidonitrogen(.)
oxoazanyl
oxyde azotique
Stickstoff(II)-oxid
Stickstoffmonoxid

Paragraph IV (Patent) Challenges for NITRIC OXIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
INOMAX	GAS;INHALATION	nitric oxide	020845	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
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No	Start Trial	Start Trial			Y	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Vero Biotech	GENOSYL	nitric oxide	GAS;INHALATION	202860-001	Dec 20, 2019		RX	Yes	Yes	Start Trial	Start Trial				Start 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	020845-003	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	Start Trial	Start Trial
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for nitric oxide

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Country	Patent Number	Estimated Expiration
Hong Kong	1220415	Start Trial
Japan	2016512112	Start Trial
Mexico	2016010359	Start Trial
Mexico	2013007931	Start Trial
Australia	2018204804	Start Trial
Australia	2015202618	Start Trial
Japan	2011010865	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for nitric oxide

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

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