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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Colorcon
Citi
Moodys
US Army
Novartis
Accenture
Dow
Covington
Baxter

Generated: October 17, 2017

DrugPatentWatch Database Preview

Sodium nitrite - Generic Drug Details

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What are the generic drug sources for sodium nitrite and what is the scope of sodium nitrite patent protection?

Sodium nitrite
is the generic ingredient in two branded drugs marketed by Hope Pharms and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are one thousand four hundred drug master file entries for sodium nitrite. One supplier is listed for this compound.

Summary for Generic Name: sodium nitrite

US Patents:4
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: see list1400
Suppliers / Packagers: see list1
Bulk Api Vendors: see list65
Clinical Trials: see list2,428
Patent Applications: see list3,961
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sodium nitrite at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hope Pharms
SODIUM NITRITE
sodium nitrite
SOLUTION;INTRAVENOUS203922-001Feb 14, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hope Pharms
SODIUM NITRITE
sodium nitrite
SOLUTION;INTRAVENOUS203922-001Feb 14, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,687,505Sodium nitrite-containing pharmaceutical compositions► Subscribe
8,920,852Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,504,709Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,597,354Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,687,506Sodium nitrite-containing pharmaceutical compositions► Subscribe
9,283,249Sodium 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 Ingredient: sodium nitrite

Country Document Number Estimated Expiration
Japan2012517474► Subscribe
Japan2015199764► Subscribe
Australia2010213743► Subscribe
Japan6059297► Subscribe
European Patent Office2395834► Subscribe
World Intellectual Property Organization (WIPO)2010093746► Subscribe
Japan5789519► Subscribe
Canada2752129► 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
C0013France► SubscribePRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
90064-1Sweden► SubscribePRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 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
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
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
C0108Belgium► SubscribePRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
2015 00014Denmark► SubscribePRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
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
C/GB98/040United Kingdom► SubscribePRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Dow
Julphar
Covington
US Department of Justice
Fuji
Daiichi Sankyo
Cipla
Mallinckrodt

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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