Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Boehringer Ingelheim
Express Scripts
Mallinckrodt
Medtronic

Last Updated: May 26, 2022

INOMAX Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 ninety-eight 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.

DrugPatentWatch® 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

< Available with Subscription >

  Sign up for a Free Trial

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
University of California, Los AngelesPhase 2
VersitiPhase 2/Phase 3
Blood Center of WisconsinPhase 2/Phase 3

See all INOMAX clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gas delivery device and system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apparatus and method for monitoring nitric oxide delivery
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
Mallinckrodt Hosp INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Patent: 10202422
Estimated Expiration: See Plans and Pricing

Patent: 10206032
Estimated Expiration: See Plans and Pricing

Patent: 12201382
Estimated Expiration: See Plans and Pricing

Patent: 15100638
Estimated Expiration: See Plans and Pricing

Patent: 15100783
Estimated Expiration: See Plans and Pricing

Patent: 15202617
Estimated Expiration: See Plans and Pricing

Patent: 15202618
Estimated Expiration: See Plans and Pricing

Patent: 16259420
Estimated Expiration: See Plans and Pricing

Patent: 17201628
Estimated Expiration: See Plans and Pricing

Patent: 17201630
Estimated Expiration: See Plans and Pricing

Patent: 17202301
Estimated Expiration: See Plans and Pricing

Patent: 18205119
Estimated Expiration: See Plans and Pricing

Patent: 20201590
Estimated Expiration: See Plans and Pricing

Patent: 22201219
Estimated Expiration: See Plans and Pricing

Canada

Patent: 71029
Estimated Expiration: See Plans and Pricing

Patent: 30908
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69614
Estimated Expiration: See Plans and Pricing

Patent: 48572
Estimated Expiration: See Plans and Pricing

Patent: 40304
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11010865
Estimated Expiration: See Plans and Pricing

Patent: 11011059
Estimated Expiration: See Plans and Pricing

Patent: 11251155
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10006055
Estimated Expiration: See Plans and Pricing

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
Germany 69133575 See Plans and Pricing
Australia 2015100783 Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013070712 See Plans and Pricing
Canada 2186892 See Plans and Pricing
Austria 316396 See Plans and Pricing
Australia 2012335937 Apparatus and method for monitoring nitric oxide delivery See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INOMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0786264 CA 2008 00019 Denmark See Plans and Pricing
1516639 300327 Netherlands See Plans and Pricing 300327, 20111205, EXPIRES: 20160731
0786264 91423 Luxembourg See Plans and Pricing 91423, EXPIRES: 20160801
1516639 C01516639/01 Switzerland See Plans and Pricing PRODUCT NAME: NITROGENII OXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56809 09.07.2004
1516639 91404 Luxembourg See Plans and Pricing 91404, EXPIRES: 20160801
0560928 CA 2002 00002 Denmark See Plans and Pricing
>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:

McKesson
Mallinckrodt
Harvard Business School
Medtronic
AstraZeneca
Colorcon

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.