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Last Updated: March 28, 2024

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INOMAX Drug Patent Profile


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Which patents cover Inomax, 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 one hundred and twelve patent family members in fifteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Inomax

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

There have been five 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

See drug prices for INOMAX

Recent Clinical Trials for INOMAX

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

SponsorPhase
Massachusetts General HospitalN/A
University of California, Los AngelesPhase 2
Medical College of 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 Strength NDA ANDAs Submitted Submissiondate
INOMAX for Inhalation nitric oxide 100 ppm and 800 ppm 020845 1 2014-05-20

US Patents and Regulatory Information for INOMAX

INOMAX is protected by four US patents.

Patents protecting INOMAX

Gas delivery device and system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Gas delivery device and system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Apparatus and method for monitoring nitric oxide delivery
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 020845-003 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for INOMAX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Linde Healthcare AB INOmax nitric oxide EMEA/H/C/000337
INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.
Authorised no no no 2001-08-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INOMAX

When does loss-of-exclusivity occur for INOMAX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09202685
Estimated Expiration: ⤷  Try a Trial

Patent: 10202422
Estimated Expiration: ⤷  Try a Trial

Patent: 10206032
Estimated Expiration: ⤷  Try a Trial

Patent: 12201382
Estimated Expiration: ⤷  Try a Trial

Patent: 15100638
Estimated Expiration: ⤷  Try a Trial

Patent: 15100783
Estimated Expiration: ⤷  Try a Trial

Patent: 15202617
Estimated Expiration: ⤷  Try a Trial

Patent: 15202618
Estimated Expiration: ⤷  Try a Trial

Patent: 16259420
Estimated Expiration: ⤷  Try a Trial

Patent: 17201628
Estimated Expiration: ⤷  Try a Trial

Patent: 17201630
Estimated Expiration: ⤷  Try a Trial

Patent: 17202301
Estimated Expiration: ⤷  Try a Trial

Patent: 18205119
Estimated Expiration: ⤷  Try a Trial

Patent: 20201590
Estimated Expiration: ⤷  Try a Trial

Patent: 22201219
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 71029
Estimated Expiration: ⤷  Try a Trial

Patent: 30908
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 69614
Estimated Expiration: ⤷  Try a Trial

Patent: 48572
Estimated Expiration: ⤷  Try a Trial

Patent: 40304
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11010865
Estimated Expiration: ⤷  Try a Trial

Patent: 11011059
Estimated Expiration: ⤷  Try a Trial

Patent: 11251155
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10006055
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INOMAX around the world.

Country Patent Number Title Estimated Expiration
Luxembourg 90886 ⤷  Try a Trial
Hong Kong 1220415 用於監測氧化氮輸送的器械和方法 (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY) ⤷  Try a Trial
Hong Kong 1076407 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INOMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0786264 SPC/GB08/019 United Kingdom ⤷  Try a Trial PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928 2002C/003 Belgium ⤷  Try a Trial PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0560928 SPC/GB02/009 United Kingdom ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.