Inhaled nitric oxide — a selective pulmonary vasodilator used for persistent pulmonary hypertension of the newborn and acute respiratory distress syndrome — is expanding into new clinical applications, with the US Medical Gases and Equipment Market reflecting the growing use of inhaled NO for cardiac surgery patients, pulmonary arterial hypertension, and emerging applications in COVID-19 pneumonia and antimicrobial applications.

Inhaled nitric oxide's selective pulmonary vasodilation — dilating well-ventilated lung units while having minimal systemic effect due to rapid hemoglobin inactivation — makes it uniquely valuable for right ventricular failure and pulmonary hypertension management in cardiac surgery, transplant recipients, and acute right heart failure. The growing cardiac surgery patient complexity — with more reoperative procedures, older patients, and higher comorbidity burden — has increased inhaled NO utilization at cardiac surgery programs.

Mallinckrodt's INOmax — the FDA-approved branded inhaled NO delivery system — has faced biosimilar competition from Linde's iNO (Airnow) product following FDA approval of the first inhaled NO generic equivalent. The $1 billion-plus annual US market for inhaled NO has attracted generic competition that is progressively reducing the extraordinary cost premium that Mallinckrodt commanded from its long-standing monopoly.

Point-of-care inhaled NO generation — using technology to produce nitric oxide from room air and nitrogen at bedside rather than from compressed gas cylinders — represents the emerging technology potentially eliminating the complex delivery system and costly cylinder logistics that conventional inhaled NO requires. Getinge's iNOvent device and research-stage NO generators represent this delivery paradigm evolution.

Do you think biosimilar and generic inhaled NO competition will reduce costs sufficiently to expand inhaled NO use to less resource-intensive clinical settings beyond major tertiary care centers?

FAQ

What is inhaled nitric oxide used for? Inhaled nitric oxide selectively dilates pulmonary blood vessels in well-ventilated lung regions, used for persistent pulmonary hypertension of the newborn, ARDS, cardiac surgery right ventricular failure, and other conditions requiring selective pulmonary vasodilation.

What is the difference between INOmax and generic inhaled nitric oxide? INOmax is Mallinckrodt's branded inhaled nitric oxide delivery system; FDA has approved generic inhaled NO products from competitors including Linde providing the same active drug at lower cost, introducing price competition to a previously monopolistic market.

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