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Nitric oxide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for nitric oxide?

Nitric oxide is the generic ingredient in one branded drug marketed by Mallinckrodt Hosp and is included in one NDA. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eighteen patent family members in nine countries.

There are six drug master file entries for nitric oxide. One supplier is listed for this compound.

Summary for Generic Name: nitric oxide

Tradenames:1
Patents:18
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Clinical Trials: see list399
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nitric oxide at DailyMed

Pharmacology for Ingredient: nitric oxide

Drug ClassVasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999DISCNYesNo8,795,741*PED► SubscribeY► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999RXYesYes8,573,210*PED► SubscribeY► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999RXYesYes8,776,795*PED► SubscribeY► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999DISCNYesNo8,431,163*PED► SubscribeY► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999DISCNYesNo8,776,794*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nitric oxide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 19995,485,827*PED► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 19995,558,083*PED► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 19995,873,359*PED► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 19995,873,359*PED► Subscribe
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 19995,558,083*PED► Subscribe
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International Patent Family for Ingredient: nitric oxide

Country Document Number Estimated Expiration
China106055863► Subscribe
World Intellectual Property Organization (WIPO)2015127085► Subscribe
Canada2779766► Subscribe
Brazil112013017498► Subscribe
New Zealand707513► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NITRIC OXIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/019United Kingdom► SubscribePRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
02C/003Belgium► SubscribePRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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