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Nitric oxide - Generic Drug Details

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

This ingredient has eleven patent family members in eight 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:16
Applicants:1
NDAs:1
Drug Master File Entries: see list6
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nitric oxide

Drug ClassVasodilator
Physiological EffectVasodilation

Clinical Trials for: nitric oxide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999RXYes8,282,966*PED<disabled>Y<disabled>
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-003Dec 23, 1999RXYes5,752,504*PED<disabled>Y<disabled>
Mallinckrodt Hosp
INOMAX
nitric oxide
GAS;INHALATION020845-002Dec 23, 1999DISCNNo8,776,794*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: nitric oxide

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

Country Document Number Estimated Expiration
Canada2779766<disabled in preview>
World Intellectual Property Organization (WIPO)2012094008<disabled in preview>
Australia2011328891<disabled in preview>
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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
02C/003Belgium<disabled>PRODUCT NAME: NITRIC OXIDE; REGISTRATION NO/DATE: EU/1/01/194/001 20010801
C/GB08/019United Kingdom<disabled>PRODUCT NAME: NITRIC OXIDE (NO); REGISTERED: UK EU/1/01/194/001 20010801
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