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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Harvard Business School
Medtronic
AstraZeneca
Colorcon

Last Updated: July 10, 2020

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INOMAX Drug Profile


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When do Inomax patents expire, and when can generic versions of Inomax launch?

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-five 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

Pharmacology for INOMAX
Drug ClassVasodilator
Physiological EffectVasodilation
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 020845-002 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
>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 CA 2008 00019 Denmark   Start Trial
1516639 07C0080 France   Start Trial PRODUCT NAME: MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
1516639 C300327 Netherlands   Start Trial PRODUCT NAME: STIKSTOFMONOXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264 2008C/013 Belgium   Start Trial PRODUCT NAME: INOMAX-MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
1516639 91404 Luxembourg   Start Trial 91404, EXPIRES: 20160801
1516639 CA 2007 00072 Denmark   Start Trial
0786264 91423 Luxembourg   Start Trial 91423, EXPIRES: 20160801
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Harvard Business School
Medtronic
AstraZeneca
Colorcon

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