Inomax is a drug owned by Mallinckrodt Pharmaceuticals Ireland 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
(2 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
(10 years from now) | Active |
| US9770570 | Apparatus and method for monitoring nitric oxide delivery |
May, 2036
(9 years from now) | Active |
|
US9279794 (Pediatric) | Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide |
Aug, 2035
(8 years from now) | Active |
| US9279794 | Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide |
Feb, 2035
(8 years from now) | Active |
|
US8573210 (Pediatric) | Nitric oxide delivery device |
Jul, 2031
(4 years from now) | Active |
|
US8573209 (Pediatric) | Gas delivery device and system |
Jul, 2031
(4 years from now) | Active |
|
US8291904 (Pediatric) | Gas delivery device and system |
Jul, 2031
(4 years from now) | Active |
|
US8776794 (Pediatric) | Nitric oxide delivery device |
Jul, 2031
(4 years from now) | Active |
|
US8776795 (Pediatric) | Gas delivery device and system |
Jul, 2031
(4 years from now) | Active |
|
US9265911 (Pediatric) | Gas delivery device and system |
Jul, 2031
(4 years from now) | Active |
|
US9408993 (Pediatric) | Nitric oxide delivery device |
Jul, 2031
(4 years from now) | Active |
|
US9295802 (Pediatric) | Gas delivery device and system |
Jul, 2031
(4 years from now) | Active |
| US8776795 | Gas delivery device and system |
Jan, 2031
(4 years from now) | Active |
| US8573210 | Nitric oxide delivery device |
Jan, 2031
(4 years from now) | Active |
| US8776794 | Nitric oxide delivery device |
Jan, 2031
(4 years from now) | Active |
| US9408993 | Nitric oxide delivery device |
Jan, 2031
(4 years from now) | Active |
| US9265911 | Gas delivery device and system |
Jan, 2031
(4 years from now) | Active |
| US9295802 | Gas delivery device and system |
Jan, 2031
(4 years from now) | Active |
| US8291904 | Gas delivery device and system |
Jan, 2031
(4 years from now) | Active |
| US8573209 | Gas delivery device and system |
Jan, 2031
(4 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
(3 years from now) | Active |
|
US8795741 (Pediatric) | Methods for treating patients who are candidates for inhaled nitric oxide treatment |
Dec, 2029
(3 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
(3 years from now) | Active |
|
US8846112 (Pediatric) | Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation |
Dec, 2029
(3 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
(3 years from now) | Active |
|
US11931377 (Pediatric) | Methods of administering inhaled nitric oxide gas |
Dec, 2029
(3 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
(2 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
(2 years from now) | Active |
| US8846112 | Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation |
Jun, 2029
(2 years from now) | Active |
| US8795741 | Methods for treating patients who are candidates for inhaled nitric oxide treatment |
Jun, 2029
(2 years from now) | Active |
| US8431163 | Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas |
Jun, 2029
(2 years from now) | Active |
|
US6125846 (Pediatric) | Purge system for nitric oxide administration apparatus |
Nov, 2017
(8 years ago) |
Expired
|
|
US5752504 (Pediatric) | System for monitoring therapy during calibration |
Jun, 2017
(9 years ago) |
Expired
|
|
US5732693 (Pediatric) | Pause control of nitric oxide therapy |
Jun, 2017
(9 years ago) |
Expired
|
| US6125846 | Purge system for nitric oxide administration apparatus |
May, 2017
(9 years ago) |
Expired
|
| US5732693 | Pause control of nitric oxide therapy |
Dec, 2016
(9 years ago) |
Expired
|
| US5752504 | System for monitoring therapy during calibration |
Dec, 2016
(9 years ago) |
Expired
|
|
US5558083 (Pediatric) | Nitric oxide delivery system |
May, 2014
(12 years ago) |
Expired
|
| US5558083 | Nitric oxide delivery system |
Nov, 2013
(12 years ago) |
Expired
|
|
US5485827 (Pediatric) | Methods and devices for treating plumonary vasoconstriction and asthma |
Jul, 2013
(13 years ago) |
Expired
|
|
US5873359 (Pediatric) | Methods and devices for treating pulmonary vasoconstriction and asthma |
Jul, 2013
(13 years ago) |
Expired
|
| US5873359 | Methods and devices for treating pulmonary vasoconstriction and asthma |
Jan, 2013
(13 years ago) |
Expired
|
| US5485827 | Methods and devices for treating plumonary vasoconstriction and asthma |
Jan, 2013
(13 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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Feb, 2026 | US8795741 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 15 Jan, 2026 | US8776794 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 15 Jan, 2026 | US8776795 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 May, 2025 | US8573210 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 May, 2025 | US8573209 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Mar, 2025 | US9770570 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Oct, 2024 | US8431163 |
| Email Notification | 14 May, 2024 | US11931377 |
| Mail Patent eCofC Notification | 14 May, 2024 | US11931377 |
| Recordation of Patent eCertificate of Correction | 14 May, 2024 | US11931377 |
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. et al., challenged the validity of this patent, with INO Therapeutics LLC et al. as the respondent. Click below to track the latest information on how companies are challenging Inomax's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8282966 | March, 2016 |
Institution Denied
(22 Sep, 2016) | Mallinckrodt Hospital Products IP Ltd. et al. | Praxair Distribution, Inc. et al. |
| US8293284 | March, 2016 |
Institution Denied
(22 Sep, 2016) | Mallinckrodt Hospital Products IP Ltd. et al. | Praxair Distribution, Inc. et al. |
| US8431163 | March, 2016 |
Institution Denied
(22 Sep, 2016) | Mallinckrodt Hospital Products IP Ltd. et al. | Praxair Distribution, Inc. et al. |
| US8795741 | March, 2016 |
Institution Denied
(22 Sep, 2016) | Mallinckrodt Hospital Products IP Ltd. et al. | Praxair Distribution, Inc. et al. |
| US8776795 | March, 2015 |
Final Written Decision
(19 Sep, 2016) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8573209 | March, 2015 |
Final Written Decision
(15 Sep, 2016) | INO THERAPEUTICS LLC et al. | Praxair Distribution, Inc. et al. |
| US8573210 | March, 2015 |
Final Written Decision
(15 Sep, 2016) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8776794 | March, 2015 |
Final Written Decision
(14 Sep, 2016) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8291904 | March, 2015 |
Final Written Decision
(12 Sep, 2016) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8846112 | March, 2016 |
Institution Denied
(25 Aug, 2016) | Mallinckrodt Hospital Products IP Ltd. et al. | Praxair Distribution, Inc. et al. |
| US8846112 | January, 2015 |
Final Written Decision
(07 Jul, 2016) | INO THERAPEUTICS LLC et al. | Praxair Distribution, Inc. et al. |
| US8282966 | January, 2015 |
Institution Denied
(29 Jul, 2015) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8293284 | January, 2015 |
Institution Denied
(29 Jul, 2015) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
| US8431163 | January, 2015 |
Institution Denied
(29 Jul, 2015) | INO THERAPEUTICS LLC et al. | Praxair Distribution, Inc. et al. |
| US8795741 | January, 2015 |
Institution Denied
(29 Jul, 2015) | INO Therapeutics LLC et al. | Praxair Distribution, Inc. et al. |
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 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Inomax:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 Vero Biotech Inc 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 | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 20 May, 2014 | 06 Jan, 2031 | Deferred | 02 Oct, 2018 | Less |
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 |
|
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 Pharmaceuticals Ireland 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 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 |