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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 sixty-two patent family members in thirteen countries.

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

Summary for INOMAX

International Patents:	62
US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	13
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	INOMAX at DailyMed

Pharmacology for INOMAX

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for INOMAX

Bronchodilator Agents

Endothelium-Dependent Relaxing Factors

Free Radical Scavengers

Gasotransmitters

Neurotransmitter Agents

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		RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999		RX	Yes	Yes					Y
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-002	Dec 23, 1999		DISCN	Yes	No					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	020845-003	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

Paragraph IV (Patent) Challenges for INOMAX

Drugname	Dosage	Strength	RLD	Submissiondate
	for Inhalation	100 ppm and 800 ppm		2014-05-20

International Patents for INOMAX

Country	Document Number	Estimated Expiration
Japan	2017507329
Mexico	2013007931
Japan	2011011059
China	103458951

Supplementary Protection Certificates for INOMAX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB08/019	United Kingdom		PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
02C/003	Belgium		PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801