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Last Updated: January 28, 2020

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INOMAX Drug Profile

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When do Inomax patents expire, and what generic alternatives are available?

Inomax is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in fifteen countries.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.

US ANDA Litigation and Generic Entry Outlook for Inomax

Inomax was eligible for patent challenges on December 23, 2003.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for INOMAX
Drug Prices for INOMAX

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Recent Clinical Trials for INOMAX

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

SponsorPhase
Blood Center of WisconsinPhase 2/Phase 3
Medical College of WisconsinPhase 2/Phase 3
Clinical & Translational Science Institute of Southeast WisconsinPhase 2/Phase 3

See all INOMAX clinical trials

Recent Litigation for INOMAX

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 INOMAX litigation

PTAB Litigation
PetitionerDate
Praxair Distribution, Inc.2016-03-23
Praxair Distribution, Inc.2015-03-16
Praxair Distribution, Inc.2015-01-05

See all INOMAX litigation

Pharmacology for INOMAX
Drug ClassVasodilator
Physiological EffectVasodilation
Synonyms for INOMAX
(.)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
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 INOMAX
Tradename Dosage Ingredient NDA Submissiondate
INOMAX GAS;INHALATION nitric oxide 020845 2014-05-20

US Patents and Regulatory Information for INOMAX

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 020845-002 Dec 23, 1999 DISCN Yes No   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
>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 INOMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
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 INOMAX

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

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