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 one hundred and seven 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
Summary for INOMAX
International Patents: | 107 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 16 |
Clinical Trials: | 15 |
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 |
---|---|
Massachusetts General Hospital | N/A |
University of California, Los Angeles | Phase 2 |
Versiti | Phase 2/Phase 3 |
Pharmacology for INOMAX
Drug Class | Vasodilator |
Physiological Effect | Vasodilation |
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: ⤷ 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 | ||
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 | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | 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 | 020845-003 | 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 |
---|---|---|---|
Norway | 2661300 | ⤷ Try a Trial | |
Spain | 2255020 | ⤷ Try a Trial | |
Netherlands | 300081 | ⤷ Try a Trial | |
Denmark | 0630270 | ⤷ 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 |
---|---|---|---|---|
1516639 | C01516639/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: NITROGENII OXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56809 09.07.2004 |
1516639 | 300327 | Netherlands | ⤷ Try a Trial | 300327, 20111205, EXPIRES: 20160731 |
0560928 | SPC/GB02/009 | United Kingdom | ⤷ Try a Trial | |
1516639 | 91404 | Luxembourg | ⤷ Try a Trial | 91404, EXPIRES: 20160801 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |