Inomax Patent Expiration

Inomax is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is protected by 44 US drug patents filed from 2013 to 2024. Out of these, 32 drug patents are active and 12 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 03, 2036. Details of Inomax's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US11931377 Methods of administering inhaled nitric oxide gas
Jun, 2029

(4 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9770570

(Pediatric)

Apparatus and method for monitoring nitric oxide delivery
Nov, 2036

(11 years from now)

Active
US9770570 Apparatus and method for monitoring nitric oxide delivery
May, 2036

(11 years from now)

Active
US9279794

(Pediatric)

Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Aug, 2034

(9 years from now)

Active
US9279794 Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
Feb, 2034

(9 years from now)

Active
US8573210

(Pediatric)

Nitric oxide delivery device
Jul, 2031

(6 years from now)

Active
US8573209

(Pediatric)

Gas delivery device and system
Jul, 2031

(6 years from now)

Active
US8776794

(Pediatric)

Nitric oxide delivery device
Jul, 2031

(6 years from now)

Active
US8776795

(Pediatric)

Gas delivery device and system
Jul, 2031

(6 years from now)

Active
US9265911

(Pediatric)

Gas delivery device and system
Jul, 2031

(6 years from now)

Active
US9408993

(Pediatric)

Nitric oxide delivery device
Jul, 2031

(6 years from now)

Active
US9295802

(Pediatric)

Gas delivery device and system
Jul, 2031

(6 years from now)

Active
US8291904

(Pediatric)

Gas delivery device and system
Jul, 2031

(6 years from now)

Active
US9408993 Nitric oxide delivery device
Jan, 2031

(6 years from now)

Active
US8573209 Gas delivery device and system
Jan, 2031

(6 years from now)

Active
US9265911 Gas delivery device and system
Jan, 2031

(6 years from now)

Active
US9295802 Gas delivery device and system
Jan, 2031

(6 years from now)

Active
US8573210 Nitric oxide delivery device
Jan, 2031

(6 years from now)

Active
US8291904 Gas delivery device and system
Jan, 2031

(6 years from now)

Active
US8776794 Nitric oxide delivery device
Jan, 2031

(6 years from now)

Active
US8776795 Gas delivery device and system
Jan, 2031

(6 years from now)

Active
US8431163

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
Dec, 2029

(5 years from now)

Active
US8282966

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
Dec, 2029

(5 years from now)

Active
US8293284

(Pediatric)

Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Dec, 2029

(5 years from now)

Active
US8795741

(Pediatric)

Methods for treating patients who are candidates for inhaled nitric oxide treatment
Dec, 2029

(5 years from now)

Active
US8846112

(Pediatric)

Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
Dec, 2029

(5 years from now)

Active
US11931377

(Pediatric)

Methods of administering inhaled nitric oxide gas
Dec, 2029

(4 years from now)

Active
US8431163 Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
Jun, 2029

(4 years from now)

Active
US8795741 Methods for treating patients who are candidates for inhaled nitric oxide treatment
Jun, 2029

(4 years from now)

Active
US8846112 Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
Jun, 2029

(4 years from now)

Active
US8293284 Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Jun, 2029

(4 years from now)

Active
US8282966 Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
Jun, 2029

(4 years from now)

Active
US6125846

(Pediatric)

Purge system for nitric oxide administration apparatus
Nov, 2017

(7 years ago)

Expired
US5752504

(Pediatric)

System for monitoring therapy during calibration
Jun, 2017

(7 years ago)

Expired
US5732693

(Pediatric)

Pause control of nitric oxide therapy
Jun, 2017

(7 years ago)

Expired
US6125846 Purge system for nitric oxide administration apparatus
May, 2017

(7 years ago)

Expired
US5752504 System for monitoring therapy during calibration
Dec, 2016

(7 years ago)

Expired
US5732693 Pause control of nitric oxide therapy
Dec, 2016

(7 years ago)

Expired
US5558083

(Pediatric)

Nitric oxide delivery system
May, 2014

(10 years ago)

Expired
US5558083 Nitric oxide delivery system
Nov, 2013

(11 years ago)

Expired
US5485827

(Pediatric)

Methods and devices for treating plumonary vasoconstriction and asthma
Jul, 2013

(11 years ago)

Expired
US5873359

(Pediatric)

Methods and devices for treating pulmonary vasoconstriction and asthma
Jul, 2013

(11 years ago)

Expired
US5485827 Methods and devices for treating plumonary vasoconstriction and asthma
Jan, 2013

(11 years ago)

Expired
US5873359 Methods and devices for treating pulmonary vasoconstriction and asthma
Jan, 2013

(11 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Inomax's patents.

Given below is the list of recent legal activities going on the following patents of Inomax.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 23 Apr, 2024 US8291904
Payment of Maintenance Fee, 8th Year, Large Entity 09 Feb, 2024 US9408993
Payment of Maintenance Fee, 8th Year, Large Entity 29 Sep, 2023 US9295802 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 08 Sep, 2023 US9279794 (Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 23 Aug, 2023 US9265911 (Litigated)
Payment of Maintenance Fee, 8th Yr, Small Entity 30 Mar, 2022 US8846112
Payment of Maintenance Fee, 8th Year, Large Entity 07 Feb, 2022 US8795741
Payment of Maintenance Fee, 8th Yr, Small Entity 17 Jan, 2022 US8776795
Payment of Maintenance Fee, 8th Yr, Small Entity 17 Jan, 2022 US8776794
Payment of Maintenance Fee, 8th Year, Large Entity 05 May, 2021 US8573210 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Inomax and ongoing litigations to help you estimate the early arrival of Inomax generic.

Inomax's Litigations

Inomax been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 05, 2015, against patent number US8795741. The petitioner Praxair Distribution, Inc., challenged the validity of this patent, with INO Therapeutics LLC as the respondent. Click below to track the latest information on how companies are challenging Inomax's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8282966 March, 2016 Terminated-Denied
(22 Sep, 2016)
Mallinckrodt Hospital Products IP Ltd. Praxair Distribution, Inc.
US8293284 March, 2016 Terminated-Denied
(22 Sep, 2016)
Mallinckrodt Hospital Products IP Ltd. Praxair Distribution, Inc.
US8431163 March, 2016 Terminated-Denied
(22 Sep, 2016)
Mallinckrodt Hospital Products IP Ltd. Praxair Distribution, Inc.
US8795741 March, 2016 Terminated-Denied
(22 Sep, 2016)
Mallinckrodt Hospital Products IP Ltd. Praxair Distribution, Inc.
US8776795 March, 2015 FWD Entered
(19 Sep, 2016)
INO Therapeutics LLC Praxair Distribution, Inc.
US8573209 March, 2015 FWD Entered
(15 Sep, 2016)
INO THERAPEUTICS LLC Praxair Distribution, Inc.
US8573210 March, 2015 FWD Entered
(15 Sep, 2016)
INO Therapeutics LLC Praxair Distribution, Inc.
US8776794 March, 2015 FWD Entered
(14 Sep, 2016)
INO Therapeutics LLC Praxair Distribution, Inc.
US8291904 March, 2015 FWD Entered
(12 Sep, 2016)
INO Therapeutics LLC Praxair Distribution, Inc.
US8846112 March, 2016 Terminated-Denied
(25 Aug, 2016)
Mallinckrodt Hospital Products IP Ltd. Praxair Distribution, Inc.
US8846112 January, 2015 FWD Entered
(07 Jul, 2016)
INO THERAPEUTICS LLC Praxair Distribution, Inc.
US8282966 January, 2015 Terminated-Denied
(29 Jul, 2015)
INO Therapeutics LLC Praxair Distribution, Inc.
US8293284 January, 2015 Terminated-Denied
(29 Jul, 2015)
INO Therapeutics LLC Praxair Distribution, Inc.
US8431163 January, 2015 Terminated-Denied
(29 Jul, 2015)
INO THERAPEUTICS LLC Praxair Distribution, Inc.
US8795741 January, 2015 Terminated-Denied
(29 Jul, 2015)
INO Therapeutics LLC Praxair Distribution, Inc.


FDA has granted some exclusivities to Inomax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Inomax, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Inomax.

Exclusivity Information

Inomax holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Inomax's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
M(M-132) Dec 21, 2013
Pediatric Exclusivity(PED) Jun 21, 2014
M(M-167) Oct 09, 2018

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Inomax is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Inomax's family patents as well as insights into ongoing legal events on those patents.

Inomax's Family Patents

Inomax has patent protection in a total of 15 countries. It's US patent count contributes only to 32.1% of its total global patent coverage. Click below to unlock the full patent family tree for Inomax.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Inomax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 03, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Inomax Generic API suppliers:

Nitric Oxide is the generic name for the brand Inomax. 2 different companies have already filed for the generic of Inomax, with Linde Gas Equip having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Inomax's generic

How can I launch a generic of Inomax before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Inomax's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Inomax's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Inomax -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 ppm and 800 ppm 20 May, 2014 1 02 Oct, 2018 06 Jan, 2031 Deferred

Alternative Brands for Inomax

Inomax which is used for treating hypoxic respiratory failure and preventing reversible vasoconstriction., has several other brand drugs using the same active ingredient (Nitric Oxide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Vero Biotech Inc
Genosyl


Apart from brand drugs containing the same ingredient, some generics have also been filed for Nitric Oxide, Inomax's active ingredient. Check the complete list of approved generic manufacturers for Inomax





About Inomax

Inomax is a drug owned by Mallinckrodt Hosp Products Ip Ltd. It is used for treating hypoxic respiratory failure and preventing reversible vasoconstriction. Inomax uses Nitric Oxide as an active ingredient. Inomax was launched by Mallinckrodt Hosp in 1999.

Approval Date:

Inomax was approved by FDA for market use on 23 December, 1999.

Active Ingredient:

Inomax uses Nitric Oxide as the active ingredient. Check out other Drugs and Companies using Nitric Oxide ingredient

Treatment:

Inomax is used for treating hypoxic respiratory failure and preventing reversible vasoconstriction.

Dosage:

Inomax is available in gas form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
800PPM GAS Prescription INHALATION
100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** GAS Discontinued INHALATION
4880PPM GAS Prescription INHALATION