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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Daiichi Sankyo
Fuji
Harvard Business School
Farmers Insurance
QuintilesIMS
Covington
McKesson
Johnson and Johnson
Queensland Health

Generated: November 19, 2017

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SODIUM NITRITE Drug Profile

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What is the patent landscape for Sodium Nitrite, and when can generic versions of Sodium Nitrite launch?

Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in five countries and twenty-nine supplementary protection certificates in seven countries.

The generic ingredient in SODIUM NITRITE is sodium nitrite. There are one thousand four hundred drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.

Medical Subject Heading (MeSH) Categories for SODIUM NITRITE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hope Pharms
SODIUM NITRITE
sodium nitrite
SOLUTION;INTRAVENOUS203922-001Feb 14, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hope Pharms
SODIUM NITRITE
sodium nitrite
SOLUTION;INTRAVENOUS203922-001Feb 14, 2012RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: SODIUM NITRITE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,920,852Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,597,354Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,687,506Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,504,709Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,283,249Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,687,505Sodium nitrite-containing pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: SODIUM NITRITE

Country Document Number Estimated Expiration
Canada2752129► Subscribe
Japan6059297► Subscribe
Japan5789519► Subscribe
Japan2012517474► Subscribe
Japan2015199764► Subscribe
World Intellectual Property Organization (WIPO)2010093746► Subscribe
Australia2010213743► Subscribe
European Patent Office2395834► 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: SODIUM NITRITE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
666Luxembourg► SubscribePRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
C/GB07/011United Kingdom► SubscribePRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C/GB98/025United Kingdom► SubscribePRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
14/058Ireland► SubscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
C0076France► SubscribePRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140514
C/GB08/036United Kingdom► SubscribePRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
C/GB97/078United Kingdom► SubscribePRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Mallinckrodt
Deloitte
Novartis
Baxter
Cipla
Medtronic
Johnson and Johnson
Julphar

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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