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Serving leading biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Accenture
Teva
UBS
Baxter
Dow
Cerilliant
AstraZeneca
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Generated: December 14, 2017

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Nitric oxide - Generic Drug Details

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What are the generic drug sources for nitric oxide and what is the scope of nitric oxide patent protection?

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.

Nitric oxide has twenty-three patent family members in nine countries and two supplementary protection certificates in two countries.

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

Pharmacology for nitric oxide

Drug ClassVasodilator
Physiological EffectVasodilation
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999DISCNYesNo► Subscribe► Subscribe► 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 HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-003Dec 23, 1999► Subscribe► Subscribe
Mallinckrodt HospINOMAXnitric oxideGAS;INHALATION020845-002Dec 23, 1999► Subscribe► Subscribe
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International Patent Family for Ingredient: nitric oxide

Country Document Number Estimated Expiration
Brazil112013017498► Subscribe
Australia2011328891► Subscribe
Australia2017204422► Subscribe
World Intellectual Property Organization (WIPO)2012094008► Subscribe
Mexico2013007931► Subscribe
Mexico346401► Subscribe
China106055863► Subscribe
Mexico2016010359► Subscribe
Australia2013257484► Subscribe
European Patent Office2661300► 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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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Argus Health
Express Scripts
Deloitte
Cantor Fitzgerald
Moodys
Queensland Health
Fuji
US Army

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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