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 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	Terminated 2023-06-16	—
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

7 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Mallinckrodt Pharmaceuticals FDA-2017-P-4360 · 12 docket documents Mallinckrodt Pharmaceuticals filed this citizen petition on July 19, 2017, requesting that the FDA establish specific regulatory requirements for any 505(b)(2) NDA or ANDA referencing INOMAX (nitric oxide) 800 ppm for inhalation as the reference listed drug, requiring that follow-on products be deli	505(q)	2017-07-21	Denied	Mallinckrodt Pharmaceuticals
Citizen Petition from Mallinckrodt Pharmaceuticals FDA-2017-P-4174 · 11 docket documents Mallinckrodt Pharmaceuticals filed this citizen petition on July 11, 2017, regarding INOMAX (nitric oxide) 800 ppm for inhalation, which is approved under NDA 20845 and administered via the INOmax DSIR delivery system cleared under 510(k). Mallinckrodt requests that the FDA ensure any follow-on drug	505(q)	2017-07-12	Withdrawn	Mallinckrodt Pharmaceuticals
Citizen Petition from Mallinckrodt Pharmaceuticals FDA-2016-P-4587 · 12 docket documents Mallinckrodt Pharmaceuticals filed this citizen petition on December 27, 2016, requesting that the FDA establish regulatory requirements for any follow-on applications referencing INOMAX (nitric oxide) 800 ppm for inhalation, including ensuring that generic or 505(b)(2) applicants use delivery syste	505(q)	2016-12-28	Denied	Mallinckrodt Pharmaceuticals
Citizen Petition from Mallinckrodt Pharmaceuticals FDA-2016-P-1955 · 7 docket documents Mallinckrodt Pharmaceuticals filed this citizen petition on June 30, 2016, requesting that the FDA designate INOMAX (nitric oxide) 800 ppm for inhalation and its associated INOmax DS Plus delivery system as a drug-device combination product, and refuse approval of any NDA or ANDA for follow-on inhal	505(q)	2016-07-08	Denied	Mallinckrodt Pharmaceuticals
Ikaria, Inc. (Kleinfeld, Kaplan, and Becker, LLP) - Citizen Petition FDA-2013-P-0070 · 10 docket documents Ikaria, Inc., through counsel Kleinfeld, Kaplan, and Becker, LLP, filed a citizen petition regarding inhaled nitric oxide, an investigational drug being developed by Ohmeda Inc. under IND 44,124 for treatment of persistent pulmonary hypertension in neonates and acute respiratory distress syndrome. T	Other	2013-02-04	Denied	—
Ikaria, Inc., (Kleinfeld, Kaplan, and Becker, LLP) - Citizen Petition FDA-2012-P-1103 · 7 docket documents Ikaria, Inc., filed this citizen petition requesting that the FDA revoke or condition the orphan drug designation granted to GeNO, LLC in June 2012 for nitric oxide to treat persistent pulmonary hypertension in newborns, the same indication for which Ikaria's subsidiary holds NDA 20-845 for INOmax (	505(q)	2012-11-05	Denied	—
12TH Man Technologies - Citizen Petition FDA-2011-P-0727 · 4 docket documents 12th Man Technologies filed a citizen petition on October 4, 2011, requesting that the FDA review and revoke the pediatric exclusivity grant awarded to INO Therapeutics for INOMax (Nitric Oxide Gas) under NDA No. 20-845, contending that the grant does not satisfy the statutory requirements of FD&C A	Other	2011-10-11	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

101 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 59 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Diffuse Optical Monitoring With Inhaled Nitric Oxide NCT03023449	Phase 2	Active	Steven Messe	40	2017-04-04 → 2026-07
The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD NCT04231760	Phase 1/2	Not Yet Recruiting	University of Alberta	80	2026-12-01 → 2028-02-01
NO During CPB in Neonates to Reduce Risk of AKI NCT04216927	Phase 3	Recruiting	Children's Hospital Medical Center, Cincinnati	40	2023-01-10 → 2026-06-30
Inhaled Nitric Oxide in Pulmonary Embolism NCT00565253	Phase 2	Completed	Medical University of Vienna	30	2005-03 → 2009-12
Clinical, Functional and Inflammatory Evaluation in Asthmatic Patients After a Simple Short-Term Educational Program NCT03655392	N/A	Completed	University of Sao Paulo	64	2015-07-01 → 2017-12-12
Validity of Fractional Exhaled Nitric Oxide and Impulse Oscillometry in Patients With Cough Variant Asthma NCT03573284	N/A	Completed	Zhujiang Hospital	146	2018-08-12 → 2019-06-30
Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies NCT00551642	Phase 3	Completed	Mallinckrodt	800	2005-05-29 → 2015-07-17
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass NCT00585013	Phase 1/2	Completed	Washington University School of Medicine	17	2008-01 → 2011-06
Comparison of Inhaled Nitric Oxide and Oxygen in Participants Reactivity During Acute Pulmonary Vasodilator Testing NCT00626028	Phase 3	Completed	Mallinckrodt	136	2004-09 → 2010-02
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis NCT00893880	Phase 2	Completed	Nitric BioTherapeutics, Inc	92	2009-06 → 2010-05

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$35.98

Highest Price

$35.98

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
64693-0002-01INOMAX 800PPM GAS	$35.98	FSS	INO Therapeutics, LLC	08/31/2026
64693-0002-02INOMAX 800PPM GAS	$35.98	FSS	INO Therapeutics, LLC	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

Date	Submission	Document
Mar 17, 2023	SUPPL -21	View Letter (PDF)
Feb 14, 2019	SUPPL -20	View Letter (PDF)
Apr 7, 2016	SUPPL -18	View Letter (PDF)
Oct 14, 2015	SUPPL -16	View Letter (PDF)
Oct 14, 2015	SUPPL -17	View Letter (PDF)
Mar 5, 2013	SUPPL -14	View Letter (PDF)
Dec 22, 2010	SUPPL -11	View Letter (PDF)
Nov 19, 2009	SUPPL -9	View Letter (PDF)
Jan 9, 2008	SUPPL -4	View Letter (PDF)
Jun 16, 2004	SUPPL -2	View Letter (PDF)
Dec 23, 1999	ORIG -1	View Letter (PDF)

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

Patents (10) · 9 use codes

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