INOMAX Drug Patent 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 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
Summary for INOMAX
International Patents: | 98 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 10 |
Clinical Trials: | 14 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INOMAX |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INOMAX |
What excipients (inactive ingredients) are in INOMAX? | INOMAX excipients list |
DailyMed Link: | INOMAX at DailyMed |


Recent Clinical Trials for INOMAX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of California, Los Angeles | Phase 2 |
Versiti | Phase 2/Phase 3 |
Blood Center of Wisconsin | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for INOMAX
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
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 |