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ULSPIRA

ANDA

NITRIC OXIDE | A203144 | AIRGAS THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: INOMAX(TE code: AA)

Hatch-Waxman Litigation

1 case 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	—

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

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.

Products (1)

#001 — 800PPM

0 patents0 exclusivities▴

GAS;INHALATION | Approved: Jul 27, 2023

No patent or exclusivity listings for this strength.