Inhaled Nitric Oxide Delivery: An Industry Update

Here’s a look at some recent milestones in the development of inhaled nitric oxide delivery.

Inhaled nitric oxide enables the relaxation of smooth muscles to dilate blood vessels within the lungs. Pharmaceutical-grade nitric oxide is used in the treatment of neonates with respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN). Indications for the delivery of nitric oxide may also include adult cardiac surgical patients and those with adult respiratory failure syndrome (ARDS). This gas is delivered with a specially designed device with a traditional critical care ventilator.

Among the attendees at the American Association for Respiratory Care (AARC) Congress held in December 2018 was Praxair, an industrial gases company with a healthcare product line including bulk gas and portable systems. The company demonstrated its NOxBOXi™ nitric oxide delivery system, which uses Noxivent, Praxair’s brand of nitric oxide. The device and cylinders of medical-grade nitric oxide will be provided via lease/usage agreements.

Eliminating the need for cylinders

AIT Therapeutics, Inc. showcased a device that eliminates the need for cylinders of nitric oxide and large delivery systems. This company has been granted a device designation by the FDA, with planned approval by 2019 or early 2020. This company has explored the use of inhaled nitric oxide in the treatment of lung infections and chronic pulmonary diseases.

In 2015 a team at Massachusetts General Hospital reported the development of their own system to generate nitric oxide. These researchers stated that they created a compact unit that produces nitric oxide from room air by an electrical spark from an iridium electrode.

More competition

Mallinckrodt Pharmaceuticals has held exclusive rights in the United States to the sale of INOMAX®, its pharmaceutical grade of inhaled nitric oxide. Used with the INOMax delivery systems, INOMAX is available via a usage agreement. INOtherapeutics/Mallikincrodt’s orphan drug designation has been set to expire in 2019. Other companies in this space have been scrambling to develop competitive technologies.

In 2016 Praxair announced the acquisition of NOxBOX Ltd., as well as approval of its Noxivent inhaled nitric oxide product for sale in Canada.

In September 2017 a ruling by a Delaware judge cleared Praxair of patent infringement connected to its generic nitric oxide product. Mallinckrodt Pharmaceuticals retained exclusive rights to sell its products in the U.S. through October 9, 2018.

Seeking less costly alternatives

As previously reported by MD Buyline analysts, the cost for treatment of a single patient can reach $18,000 with INOMAX. The MD Buyline database includes agreements for over $1 million in annual spending for member hospitals. Hospital administrators report that they have been searching for an alternative to INOtherapy for nitric oxide delivery.

If your hospital is using inhaled nitric oxide, we would like to learn about your challenges. Please contact Kathey Leibold at  

Kathey Leibold, Clinical Analyst

Kathey Leibold joined MD Buyline in 2002 with over 24 years’ experience in respiratory care for the neonatal, pediatric, cardiac, and neurocritical care units.