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INOMAX Drug Patent 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 seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twelve patent family members in fifteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Inomax

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

There have been five 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

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Summary for INOMAX

International Patents:	112
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	15
Drug Prices:	Drug price information for INOMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INOMAX
What excipients (inactive ingredients) are in INOMAX?	INOMAX excipients list
DailyMed Link:	INOMAX at DailyMed

Drug patent expirations by year for INOMAX

Recent Clinical Trials for INOMAX

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

Sponsor	Phase
Massachusetts General Hospital	N/A
University of California, Los Angeles	Phase 2
Mallinckrodt	Phase 2/Phase 3

See all INOMAX clinical trials

Pharmacology for INOMAX

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for INOMAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INOMAX	for Inhalation	nitric oxide	100 ppm and 800 ppm	020845	1	2014-05-20

US Patents and Regulatory Information for INOMAX

INOMAX is protected by six US patents.

Patents protecting INOMAX

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Patented Use: A METHOD FOR TREATING A PEDIATRIC PATIENT WHO IS EXPERIENCING IDIOPATHIC PULMONARY ARTERIAL HYPERTENSION RESULTING IN OXYGEN DESATURATION, WHEREIN THE PATIENT IS NOT DEPENDENT ON RIGHT-TO-LEFT SHUNTING OF BLOOD

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Gas delivery device and system
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Systems and methods for compensating long term sensitivity drift of electrochemical gas sensors exposed to nitric oxide
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Patent Expiration: ⤷ Sign Up

Gas delivery device and system
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Apparatus and method for monitoring nitric oxide delivery
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Glossary

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

Expired US Patents for INOMAX

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

EU/EMA Drug Approvals for INOMAX

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Linde Healthcare AB	INOmax	nitric oxide	EMEA/H/C/000337 INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated:for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;as part of the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation.	Authorised	no	no	no	2001-08-01
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for INOMAX

When does loss-of-exclusivity occur for INOMAX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 09202685
Estimated Expiration: ⤷ Sign Up

Patent: 10202422
Patent: Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
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Patent: 10206032
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
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Patent: 12201382
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 15100638
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 15100783
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 15202617
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 15202618
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 16259420
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 17201628
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 17201630
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 17202301
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 18205119
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 20201590
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Patent: 22201219
Patent: Methods of treating patients having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 71029
Patent: PROCEDES DESTINES AU TRAITEMENT DES NOUVEAU-NES A TERME OU PRESQUE A TERME ATTEINTS D'UNE INSUFFISANCE RESPIRATOIRE HYPOXIQUE ASSOCIEE A DES SIGNES CLINIQUES OU ECHOCARDIOGRAPHIQUES D'HYPERTENSION PULMONAIRE (METHODS OF TREATING TERM AND NEAR-TERM NEONATES HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION)
Estimated Expiration: ⤷ Sign Up

Patent: 30908
Patent: PROCEDES DESTINES AU TRAITEMENT DES NOUVEAU-NES A TERME OU PRESQUE A TERME ATTEINTS D'UNE INSUFFISANCE RESPIRATOIRE HYPOXIQUE ASSOCIEE A DES SIGNES CLINIQUES OU ECHOCARDIOGRAPHIQUES D'HYPERTENSION PULMONAIRE (METHODS OF TREATING TERM AND NEAR-TERM NEONATES HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 69614
Patent: Procédé d'identification d'une population de patients éligibles au traitement au monoxyde d'azote (A method of identifying a patient population suited to receiving nitric oxide)
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Patent: 48572
Patent: PROCÉDÉS D'IDENTIFICATION D'UNE POPULATION DE PATIENTS ÉLIGIBLES POUR LE TRAITEMENT AVEC DE L'OXYDE NITRIQUE PAR INHALATION (METHODS OF IDENTIFYING A PATIENT POPULATION ELIGIBLE FOR TREATMENT WITH NITRIC OXIDE VIA INHALATION)
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Patent: 40304
Patent: Procédés pour réduire le risque ou prévenir l'apparition d'un événement défavorable ou d'un événement défavorable grave associés au traitement par oxyde nitrique inhalé (Methods for reducing the risk or preventing the occurrence of an adverse event or serious adverse event associated with the inhalation of nitric oxide treatment)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 11010865
Patent: METHOD OF TREATING TERM AND NEAR-TERM NEONATE HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION
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Patent: 11011059
Patent: METHOD OF TREATING INFANT HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC OF EVIDENCE OF PULMONARY HYPERTENSION
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Patent: 11251155
Patent: METHOD OF TREATING TERM AND NEAR-TERM NEONATE HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 10006055
Patent: METODOS DE TRATAMIENTO DE RECIEN NACIDOS Y CASI A PUNTO DE NACER QUE TIENEN FALLAS RESPIRATORIAS HIPOXICAS ASOCIADA CON EVIDENCIA CLINICA O ECOCARDIOGRAFICA DE HIPERTENSION PULMONAR. (METHODS OF TREATING TERM AND NEAR-TERM NEONATES HAVING HYPOXIC RESPIRATORY FAILURE ASSOCIATED WITH CLINICAL OR ECHOCARDIOGRAPHIC EVIDENCE OF PULMONARY HYPERTENSION.)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INOMAX around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2010202422	Methods of treating term and near-term neonates having hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension	⤷ Sign Up
Mexico	2016010359	SISTEMAS Y METODOS PARA COMPENSAR A LARGO PLAZO LA SENSIBILIDAD DE LA DERIVA DE SENSORES ELECTROQUIMICOS DE GAS EXPUESTOS A OXIDO NITRICO. (METHODS FOR COMPENSATING LONG TERM SENSITIVITY DRIFT OF ELECTROCHEMICAL GAS SENSORS EXPOSED TO NITRIC OXIDE.)	⤷ Sign Up
Germany	69424386		⤷ Sign Up
Canada	2186892		⤷ Sign Up
Spain	2224123		⤷ Sign Up
Brazil	112013017498	dispositivo e sistema de distribuição de gás	⤷ Sign Up
Canada	2905644	APPAREIL ET PROCEDE POUR LA SURVEILLANCE DE L'ADMINISTRATION D'OXYDE NITRIQUE (APPARATUS AND METHOD FOR MONITORING NITRIC OXIDE DELIVERY)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for INOMAX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0560928	SPC/GB02/009	United Kingdom	⤷ Sign Up
0786264	SPC/GB08/019	United Kingdom	⤷ Sign Up	PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
0560928	2002C/003	Belgium	⤷ Sign Up	PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
0786264	2008C/013	Belgium	⤷ Sign Up	PRODUCT NAME: INOMAX-MONOXYDE D AZOTE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
1516639	CA 2007 00072	Denmark	⤷ Sign Up
1516639	C01516639/01	Switzerland	⤷ Sign Up	PRODUCT NAME: NITROGENII OXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56809 09.07.2004
0786264	CA 2008 00019	Denmark	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description