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Generated: November 16, 2018

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Nitric oxide - Generic Drug Details

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

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.

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

Pharmacology for nitric oxide
Drug ClassVasodilator
Physiological EffectVasodilation
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 ➤ Sign Up ➤ Sign Up
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for nitric oxide

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

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Merck
Citi
Harvard Business School
US Army
Queensland Health
QuintilesIMS
Cantor Fitzgerald
Baxter

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