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INOMAX Drug Profile

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When do Inomax patents expire, and what generic alternatives are available?

Inomax is a drug marketed by Mallinckrodt Hosp and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in fifteen countries.

The generic ingredient in INOMAX is nitric oxide. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.

US ANDA Litigation and Generic Entry Outlook for Inomax

Inomax was eligible for patent challenges on December 23, 2003.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INOMAX

International Patents:	82
US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	11
Clinical Trials:	14
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INOMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INOMAX
DailyMed Link:	INOMAX at DailyMed

See drug prices for INOMAX

Recent Clinical Trials for INOMAX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Blood Center of Wisconsin	Phase 2/Phase 3
Medical College of Wisconsin	Phase 2/Phase 3
Clinical & Translational Science Institute of Southeast Wisconsin	Phase 2/Phase 3

See all INOMAX clinical trials

Recent Litigation for INOMAX

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc.	2016-07-08
Mallinckrodt Hospital Products IP Ltd. v. Praxair Distribution Inc.	2015-02-19

See all INOMAX litigation

PTAB Litigation

Petitioner	Date
Praxair Distribution, Inc.	2016-03-23
Praxair Distribution, Inc.	2015-03-16
Praxair Distribution, Inc.	2015-01-05

See all INOMAX litigation

Pharmacology for INOMAX

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Synonyms for INOMAX

(.)NO

(NO)(.)

[NO]

10102-43-9

AC1L3QHF

C00533

CHEBI:16480

CHEMBL1200689

CTK0H7679

D00074

DB00435

DTXSID1020938

EDRF

endothelium-derived relaxing factor

INOmax (TN)

Mononitrogen monoxide

monoxido de nitrogeno

monoxyde d'azote

nitric oxide

Nitric oxide (JAN)

Nitric oxide trimer

Nitric oxide, 98.5%

nitrogen monooxide

nitrogen monoxide

nitrogen protoxide

Nitrogen(II) oxide

Nitrosoradical

nitrosyl

Nitrosyl radical

NO(.)

OHM 11771

oxido de nitrogeno(II)

oxido nitrico

oxidonitrogen(.)

oxoazanyl

oxyde azotique

Stickstoff(II)-oxid

Stickstoffmonoxid

Paragraph IV (Patent) Challenges for INOMAX

Tradename	Dosage	Ingredient	NDA	Submissiondate
INOMAX	GAS;INHALATION	nitric oxide	020845	2014-05-20

US Patents and Regulatory Information for INOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999	AA	RX	Yes	Yes					Y

Expired US Patents for INOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999

International Patents for INOMAX

Country	Patent Number	Estimated Expiration
Canada	2854776
Japan	2019013763
China	103458951
Canada	2939094
Japan	2011010865
Mexico	2014005524
Brazil	112013017498

Supplementary Protection Certificates for INOMAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0786264	SPC/GB08/019	United Kingdom		PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801