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INOMAX Drug Profile

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When do Inomax patents expire, and when can generic versions of Inomax launch?

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.

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

US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	12
Clinical Trials:	13
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

Generic Entry Opportunity Date for INOMAX

Constraining patent/regulatory exclusivity:

APPROVED FOR REVISIONS TO THE LABELING BASED ON THE CLINICAL STUDY ENTITLED 'BRONCHOPULMONARY DYSPLASIA (BPD) IN PRETERM INFANTS REQUIRING MECHANICAL VENTILATION OR POSITIVE PRESSURE SUPPORT ON DAYS 5 TO 14 AFTER BIRTH'.

NDA:

020845

Dosage:

GAS;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
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

Expired US Patents for INOMAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	INOMAX	nitric oxide	GAS;INHALATION	020845-003	Dec 23, 1999
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	020845-002	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	Date
	for Inhalation	100 ppm and 800 ppm

International Patents for INOMAX

Country	Document Number	Estimated Expiration
Canada	2671029
Australia	2017202301
Australia	2010202422
Australia	2011328891
World Intellectual Property Organization (WIPO)	2014159912
Canada	2779766

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