Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00777	8282966	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2016-03-23	—
IPR2015-00522	8282966	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2015-01-05	—
IPR2015-00884	8291904	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-03-16	—
IPR2016-00779	8293284	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2016-03-23	—
IPR2015-00524	8293284	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2015-01-05	—
IPR2016-00778	8431163	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2016-03-23	—
IPR2015-00525	8431163	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2015-01-05	—
IPR2015-00889	8573209	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-03-16	—
IPR2015-00891	8573210	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-03-16	—
IPR2015-00888	8776794	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-03-16	—
IPR2015-00893	8776795	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-03-16	—
IPR2016-00780	8795741	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2016-03-23	—
IPR2015-00526	8795741	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2015-01-05	—
IPR2016-00781	8846112	IPR	Praxair Distribution, Inc. et al.	Institution Denied	2016-03-23	—
IPR2015-00529	8846112	IPR	Praxair Distribution, Inc. et al.	Final Written Decision	2015-01-05	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Mallinckrodt Pharmaceuticals Ireland Limited et al v. Airgas Therapeutics LLC et al 1:2022cv01648 14 patentsANDA 203144Nitric Oxide Gas for Inhalation	D. Del.	2022-12-30	Active	—
Mallinckrodt Hospital Products IP Ltd. et al v. Praxair Distribution Inc. et al 1:2015cv00170 10 patentsANDA 207141nitric oxide	D. Del.	2015-02-19	Terminated 2019-12-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

8 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of a Daily Supplement on Plasma PAI-1 Levels NCT07469475	Phase 1/2	Active	University of California, Los Angeles	35	2026-02-24 → 2026-12
Quantifying the Burden of Type 2 (T2) Inflammation in Asthma NCT07675044	—	Not Yet Recruiting	Icahn School of Medicine at Mount Sinai	200	2026-07 → 2027-05
Comparative Evaluation of Nicotine Analogs NCT07585006	Phase 1	Recruiting	Ohio State University Comprehensive Cancer Center	70	2026-05-29 → 2026-12-31
Hydroponic vs Conventional Spinach Smoothies: Effects on Salivary Nitrate Bioavailability and Blood Pressure NCT07665944	N/A	Recruiting	University of Plymouth	12	2026-05-22 → 2026-07-31
Natural History of Sickle Cell Disease NCT00081523	—	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	3,500	2004-04-29
Combined Air-plasma Flow and Nitric Oxide Therapy in Cardiac Surgery NCT04617353	N/A	Completed	Tomsk National Research Medical Center of the Russian Academy of Sciences	80	2017-03-14 → 2023-12-20
High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB NCT06261827	N/A	Completed	Tomsk National Research Medical Center of the Russian Academy of Sciences	160	2024-02-20 → 2025-10-01
High-dose Inhaled NO Therapy for the Prevention of Nosocomial Pneumonia After Cardiac Surgery With CPB NCT06162455	N/A	Completed	Tomsk National Research Medical Center of the Russian Academy of Sciences	74	2023-11-17 → 2024-02-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

AIRGAS THERAPEUTICS LLCNITRIC OXIDE

DMF 247632011

LIQUID CARBONIC INDUSTRIES CORP BULK GASESInactiveNITRIC OXIDE IN NITROGEN GAS MIXTURE PRODUCED IN OAK BROOK, ILLINOIS

DMF 105101993

PURITAN BENNETT CORPInactiveNITRIC OXIDE IN NITROGEN GAS MIXTURE

DMF 113991995

INO THERAPEUTICS INCInactiveNITRIC OXIDE FOR INHALATION, 800PPM

DMF 174722004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

10 patents0 exclusivities▴

GAS;INHALATION | Approved: Dec 23, 1999

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8282966	Jun 30, 2029PED: Dec 30, 2029	PED	—	—		—
8291904	Jan 6, 2031PED: Jul 6, 2031	PED	—	Yes		—
8293284	Jun 30, 2029PED: Dec 30, 2029	PED	—	—		—
8431163	Jun 30, 2029PED: Dec 30, 2029	PED	—	—		—
8573209	Jan 6, 2031PED: Jul 6, 2031	PED	—	Yes	—	—
8573210	Jan 6, 2031PED: Jul 6, 2031	PED	—	Yes		—
8776794	Jan 6, 2031PED: Jul 6, 2031	PED	—	Yes		—
8776795	Jan 6, 2031PED: Jul 6, 2031	PED	—	Yes		—
8795741	Jun 30, 2029PED: Dec 30, 2029	PED	—	—		—
8846112	Jun 30, 2029PED: Dec 30, 2029	PED	—	—		—

#003 — 800PPM

RLDAA

16 patents0 exclusivities▾

GAS;INHALATION | Approved: Dec 23, 1999

#004 — 4880PPM

RLD

1 patent0 exclusivities▾

GAS;INHALATION | Approved: Jan 17, 2023