IP Library › Granted Patent US 12,653,837
Granted Patent B2
US 12,653,837 · App. 16/961,886 · Granted Jun 16, 2026

Use of inhaled nitric oxide and oxygen for the treatment of pulmonary hypertension

Inventors: Deborah Quinn (Morristown, NJ); Parag Shah (Morristown, NJ)
Assignee: Malinckrodt Pharmaceuticals Ireland Limited
A61K33/00A61K9/007A61M16/12A61P11/00A61M2202/0208A61M2202/0275
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,653,837
App. No.
16/961,886
Granted
Jun 16, 2026
Kind
B2
Abstract

Described herein are methods of using inhaled nitric oxide for treating pulmonary hypertension, improving exercise capacity and/or reducing oxygen desaturation in a patient.

Claims (16)

1 . A method of reducing oxygen desaturation in a patient with WHO Group 3 pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF), the method comprising:

administering an effective amount of inhaled nitric oxide (iNO) in combination with an effective amount of long-term oxygen therapy (LTOT) to a patient in need thereof, wherein the iNO is administered at a dose of about 50 to about 100 mcg/kg IBW/hr for at least 6 hours a day for at least 4 weeks.

2 . A method of treating WHO Group 3 pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF), the method comprising:

administering an effective amount of inhaled nitric oxide (iNO) in combination with an effective amount of long-term oxygen therapy (LTOT) to a patient in need thereof, wherein the iNO is administered at a dose of about 50 to about 100 mcg/kg IBW/hr for at least 6 hours a day for at least 4 weeks.

3 . A method of improving exercise capacity in a patient with WHO Group 3 pulmonary hypertension associated with idiopathic pulmonary fibrosis (PH-IPF), the method comprising:

administering an effective amount of inhaled nitric oxide (iNO) in combination with an effective amount of long-term oxygen therapy (LTOT) to a patient in need thereof, wherein the iNO is administered at a dose of about 50 to about 100 mcg/kg IBW/hr for at least 6 hours a day for at least 4 weeks.

4 . The method of claim 2 , wherein the iNO is administered to the patient during the first half of inspiration.

5 . The method of claim 2 , wherein the iNO is administered for at least 12 hours a day.

6 . The method of claim 2 , wherein the patient has a ventilation-perfusion (V/Q) mismatch.

7 . The method of claim 2 , wherein the iNO is administered for at least 3 months.

8 . The method of claim 2 , wherein the iNO is administered at a dose of about 50 mcg/kg IBW/hr to about 75 mcg/kg IBW/hr.

9 . The method of claim 2 , wherein the iNO is administered at a dose of about 75 mcg/kg IBW/hr.

10 . The method of claim 2 , wherein the administration of iNO provides an average decrease in the reduction of SpO2 during exercise in a group of patients after 16 weeks of iNO administration of at least 1.

11 . The method of claim 2 , wherein the administration of iNO provides an average decrease in the reduction of SpO2 during exercise in a group of patients after 16 weeks of iNO administration of about 3.36.

12 . The method of claim 2 , wherein the administration of iNO provides an average increase in six-minute walk distance (6MWD) exercise in a group of patients after 16 weeks of iNO administration of at least 10 meters.

13 . The method of a claim 2 , wherein the administration of iNO provides an average increase in six-minute walk distance (6MWD) in a group of patients after 16 weeks of iNO administration of about 52.4 meters.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 72331 FRAME 1. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 075021/0204 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF US PATENT 10828415 AND REMOVE IT FROM THE LISTING PREVIOUSLY RECORDED ON REEL 73375 FRAME 395. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Mar 6, 2026
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 075021/0263 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2026
From: QUINN, DEBORAH; SHAH, PARAG
To: BELLEROPHON PULSE TECNOLOGIES LLC
Reel/Frame 073910/0465 →
SECURITY INTEREST Recorded Oct 28, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: GOLDMAN SACHS BANK USA, AS ADMINISTRATIVE AGENT
Reel/Frame 073375/0395 →
SECURITY INTEREST Recorded Aug 1, 2025
From: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: COMPUTERSHARE TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 072331/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 10, 2024
From: BELLEROPHON THERAPEUTICS, INC. / BELLEROPHON PULSE TECHNOLOGIES LLC
To: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 067678/0618 →
Continuity (2)
Provisional Application 62611316 · Dec 28, 2017
Related Publication 20200360425A1 · Nov 19, 2020
References Cited (6)
US 20080051882A1 · Rubin · 2008 [cited by examiner]
US 20170165447A1 · Dasse · 2017 [cited by examiner]
US 20170232166A1 · Potenziano · 2017 [cited by examiner]
Behr, J et al. “Pulmonary hypertension in interstitial lung disease” Eur Respir J 2008; 31: 1357-1367 (Year: 2008). [cited by examiner]
Pochis, W.T. et al. “Idiopathic pulmonary fibrosis. A rare cause of scintigraphic ventilation-perfusion mismatch” Clin Nucl Med. May 1990;15(5):321-3 (Year: 1990). [cited by examiner]
Yoshida, M. et al. “The effect of low-dose inhalation of nitric oxide in patients with pulmonary fibrosis” Eur Respir J 1997; 10: 2051-2054 (Year: 1997). [cited by examiner]