Skip to Content

Generic INOmax Availability

INOmax is a brand name of nitric oxide, approved by the FDA in the following formulation(s):

INOMAX (nitric oxide - gas;inhalation)

  • Manufacturer: MALLINCKRODT HOSP
    Approval date: December 23, 1999
    Strength(s): 100PPM, 800PPM [RLD]

Has a generic version of INOmax been approved?

No. There is currently no therapeutically equivalent version of INOmax available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of INOmax. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Pause control of nitric oxide therapy
    Patent 5,732,693
    Issued: March 31, 1998
    Inventor(s): Bathe; Duncan P. L. & Kohlmann; Thomas S. & Tham; Robert Q.
    Assignee(s): Ohmeda Inc.
    A system for the delivery of nitric oxide therapy to a patient that allows interventions by a user by activating a pause mode through a user input. A CPU in the system recognizes the activation of the pause mode and sends a signal to close a valve in order to discontinue the supply of nitric oxide to the patient. The activation of the pause mode also deactivates the normal alarm systems. A timer is activated when the system enters the pause mode and the timer allows a predetermined amount of time to pass while the pause mode is in effect. After that predetermined period of time has elapsed, the timer causes the CPU to reopen the valve to reestablish the flow of nitric oxide for the continued therapy and reestablish the alarm systems. The pause mode can be thus carried out without changing any alarm settings, established flows and the like so that the therapy is again recommenced at the same conditions as were in effect prior to the initiation of the pause mode.
    Patent expiration dates:
    • December 13, 2016
      ✓ 
      Patent use: A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT
      ✓ 
      Drug product
    • June 13, 2017
      ✓ 
      Pediatric exclusivity
  • System for monitoring therapy during calibration
    Patent 5,752,504
    Issued: May 19, 1998
    Inventor(s): Bathe; Duncan P. L.
    Assignee(s): Ohmeda Inc.
    A system for continuing the monitoring of certain gases delivered to a patient during the administration of nitric oxide to provide therapy to the patient. The nitric oxide is controlled by a electrically operated valve that is operated by means of an electrical signal from a CPU. At times when the various gas monitors are being calibrated, the normal alarms based upon those gas monitors are conventionally disabled during that calibration time. With the present invention, the electrical signal to the electrically operated valve is detected at the time the system goes into a calibration cycle and that detected electrical signal is used to establish limits such as a upper limit and a lower limit. Therefore, when the electrical signal to the valve is thereafter monitored and its value exceeds either of those limits, the overall nitric oxide delivery system will activate an alarm to alert the user of an abnormal condition. Thus an alarm system is present even when the various gas monitors are otherwise taken out of the system during their calibration.
    Patent expiration dates:
    • December 13, 2016
      ✓ 
      Patent use: A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT
      ✓ 
      Drug product
    • June 13, 2017
      ✓ 
      Pediatric exclusivity
  • Purge system for nitric oxide administration apparatus
    Patent 6,125,846
    Issued: October 3, 2000
    Inventor(s): Bathe; Duncan P. L. & Montgomery; Frederick J.
    Assignee(s): Datex-Ohmeda, Inc.
    A nitric oxide delivery system is disclosed that delivers a pulsed volume of NO containing therapeutic gas to a patient upon each inhalation of the patient. The NO delivery system includes certain functions to provide protection against the inadvertent inclusion of NO.sub.2 in the therapeutic gas administered to the patient. One of the functions is to provide a purge upon start up of the delivery system apparatus that clears the regulator and conduits of any NO.sub.2 that may have formed during the prior idle period of the system. A detector determines the start-up and may automatically carry out the purge cycle or may cause a prompt that is visual or audible to remind the user to carry out the purge cycle manually. As a further function, when the NO apparatus is terminated with respect to a patient, the system can, again, sense the termination or cessation of the therapy and automatically shut off the supply of NO containing gas at the source or provide an audible or visual prompt to remind the user to shut off the supply of the NO containing gas manually.
    Patent expiration dates:
    • May 16, 2017
      ✓ 
      Patent use: A METHOD OF PURGING A NITRIC OXIDE DELIVERY SYSTEM
      ✓ 
      Drug product
    • November 16, 2017
      ✓ 
      Pediatric exclusivity
  • Methods of reducing the risk of occurrence of pulmonary edema in children in need of treatment with inhaled nitric oxide
    Patent 8,282,966
    Issued: October 9, 2012
    Inventor(s): Baldassarre; James S. & Rosskamp; Ralf
    Assignee(s): INO Therapeutics LLC
    The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
    Patent expiration dates:
    • June 30, 2029
      ✓ 
      Patent use: A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
    • December 30, 2029
      ✓ 
      Pediatric exclusivity
  • Gas delivery device and system
    Patent 8,291,904
    Issued: October 23, 2012
    Inventor(s): Bathe; Duncan P. & Klaus; John & Christensen; David
    Assignee(s): INO Therapeutics LLC
    A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
    Patent 8,293,284
    Issued: October 23, 2012
    Inventor(s): Baldassarre; James S. & Rosskamp; Ralf
    Assignee(s): INO Therapeutics LLC
    The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
    Patent expiration dates:
    • June 30, 2029
      ✓ 
      Patent use: A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
    • December 30, 2029
      ✓ 
      Pediatric exclusivity
  • Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
    Patent 8,431,163
    Issued: April 30, 2013
    Assignee(s): INO Therapeutics LLC
    Disclosed are methods of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of nitric oxide gas.
    Patent expiration dates:
    • June 30, 2029
      ✓ 
      Patent use: A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
    • December 30, 2029
      ✓ 
      Pediatric exclusivity
  • Gas delivery device and system
    Patent 8,573,209
    Issued: November 5, 2013
    Assignee(s): INO Therapeutics LLC
    A gas delivery system including a gas delivery device (100), a control module (200) and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve (107) assembly with a valve and circuit including a memory (134), a processor (122) and a transceiver (120) in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator (400) and a breathing circuit (410). Methods of administering gas are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Nitric oxide delivery device
    Patent 8,573,210
    Issued: November 5, 2013
    Assignee(s): INO Therapeutics LLC
    A nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Nitric oxide delivery device
    Patent 8,776,794
    Issued: July 15, 2014
    Assignee(s): INO Therapeutics LLC
    A nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Gas delivery device and system
    Patent 8,776,795
    Issued: July 15, 2014
    Assignee(s): INO Therapeutics LLC
    A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Methods for treating patients who are candidates for inhaled nitric oxide treatment
    Patent 8,795,741
    Issued: August 5, 2014
    Assignee(s): INO Therapeutics LLC
    Disclosed are methods of reducing the risk that a medical treatment comprising inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure in the patient, leading to pulmonary edema.
    Patent expiration dates:
    • June 30, 2029
      ✓ 
      Patent use: A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
    • December 30, 2029
      ✓ 
      Pediatric exclusivity
  • Methods of distributing a pharmaceutical product comprising nitric oxide gas for inhalation
    Patent 8,846,112
    Issued: September 30, 2014
    Assignee(s): INO Therapeutics LLC
    Disclosed are methods of distributing a pharmaceutical product comprising nitric oxide gas. The methods include supplying a source of nitric oxide gas to a medical provider, informing the medical provider about a recommended dose of inhaled nitric oxide gas for treatment of neonates with hypoxic respiratory failure, and providing a warning about use of inhaled nitric oxide in patients with pre-existing left ventricular dysfunction.
    Patent expiration dates:
    • June 30, 2029
      ✓ 
      Patent use: A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT WITH INHALED NITRIC OXIDE
    • December 30, 2029
      ✓ 
      Pediatric exclusivity
  • Gas delivery device and system
    Patent 9,265,911
    Issued: February 23, 2016
    Assignee(s): Mallinckrodt Hospital Products IP Limited
    A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
    Patent 9,279,794
    Issued: March 8, 2016
    Assignee(s): Mallinckrodt Hospital Products IP Limited
    Described are systems and methods for compensating long term sensitivity drift of catalytic type electrochemical gas sensors used in systems for delivering therapeutic nitric oxide (NO) gas to a patient by compensating for drift that may be specific to the sensors atypical use in systems for delivering therapeutic nitric oxide gas to a patient. In at least some instances, the long term sensitivity drift of catalytic type electrochemical gas sensors can be addressed using calibration schedules, which can factor in the absolute change in set dose of NO being delivered to the patient that can drive one or more baseline calibrations. The calibration schedules can be used reduce the amount of times the sensor goes offline. Systems and methods described may factor in in actions occurring at the delivery system and/or aspects of the surrounding environment, prior to performing a baseline calibration, and may postpone the calibration and/or rejected using the sensor's output for the calibration.
    Patent expiration dates:
    • February 19, 2034
      ✓ 
      Patent use: A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY COMPENSATING LONG-TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS USED IN SYSTEMS FOR DELIVERING THERAPEUTIC NITRIC OXIDE TO A PATIENT
      ✓ 
      Drug product
    • August 19, 2034
      ✓ 
      Pediatric exclusivity
  • Gas delivery device and system
    Patent 9,295,802
    Issued: March 29, 2016
    Assignee(s): Mallinckrodt Hospital Products IP Limited
    A gas delivery system including a gas delivery device, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gas are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity
  • Nitric oxide delivery device
    Patent 9,408,993
    Issued: August 9, 2016
    Assignee(s): Mallinckrodt Hospital Products IP Limited
    A nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
    Patent expiration dates:
    • January 6, 2031
      ✓ 
      Patent use: A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT BY VERIFYING GAS INFORMATION OF NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
      ✓ 
      Drug product
    • July 6, 2031
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • October 9, 2018 - APPROVED FOR REVISIONS TO THE LABELING BASED ON THE CLINICAL STUDY ENTITLED 'BRONCHOPULMONARY DYSPLASIA (BPD) IN PRETERM INFANTS REQUIRING MECHANICAL VENTILATION OR POSITIVE PRESSURE SUPPORT ON DAYS 5 TO 14 AFTER BIRTH'.

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
Hide