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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Moodys
AstraZeneca
Boehringer Ingelheim
Merck

Last Updated: November 20, 2019

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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 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.

Nitric oxide has seventy-nine patent family members in fifteen countries.

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

Recent Clinical Trials for NITRIC OXIDE

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

SponsorPhase
Lund UniversityPhase 4
ALK-Abelló A/SPhase 4
Bispebjerg HospitalPhase 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
Praxair Distribution, Inc.2016-03-23
Praxair Distribution, Inc.2015-03-16
Praxair Distribution, Inc.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
AC1L3QHF
C00533
CHEBI:16480
CHEMBL1200689
CTK0H7679
D00074
DB00435
DTXSID1020938
EDRF
endothelium-derived relaxing factor
INOmax (TN)
Mononitrogen monoxide
monoxido de nitrogeno
monoxyde d'azote
Nitric oxide (JAN)
Nitric oxide trimer
Nitric oxide, 98.5%
nitrogen monooxide
nitrogen monoxide
nitrogen protoxide
Nitrogen(II) oxide
Nitrosoradical
nitrosyl
Nitrosyl radical
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 020845-003 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 020845-002 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 020845-002 Dec 23, 1999 DISCN Yes No   Start Trial   Start Trial Y   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 020845-002 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
0786264 SPC/GB08/019 United Kingdom   Start Trial PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928 2002C/003 Belgium   Start Trial 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

Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Mallinckrodt
McKesson
Express Scripts
Johnson and Johnson

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