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Last Updated: April 2, 2020

DrugPatentWatch Database Preview

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.

Recent Clinical Trials for nitric oxide

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

SponsorPhase
Joshua KorzenikPhase 2
Lund UniversityPhase 4
ALK-Abelló A/SPhase 4

See all nitric oxide clinical trials

Recent Litigation for nitric oxide

Identify potential future generic entrants

District Court Litigation
Case NameDate
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
PetitionerDate
2016-03-23
2015-03-16
2015-01-05

See all nitric oxide litigation

Pharmacology for nitric oxide
Drug ClassVasodilator
Physiological EffectVasodilation
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

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

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

Supplementary Protection Certificates for nitric oxide

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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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Colorcon
Dow
Merck
Baxter

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.