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NITHIODOTE Drug Profile

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Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug.

This drug has fourteen patent family members in five countries.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There are one thousand three hundred and fifty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite; sodium thiosulfate profile page.

Summary for Tradename: NITHIODOTE

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYes8,496,973► subscribeYY ► subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYes8,568,793► subscribeYY ► subscribe
Hope Pharms
NITHIODOTE
sodium nitrite; sodium thiosulfate
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS201444-001Jan 14, 2011RXYes► subscribe► subscribe
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Non-Orange Book Patents for Tradename: NITHIODOTE

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
8,715,746Sodium thiosulfate-containing pharmaceutical compositions► subscribe
8,920,852Sodium 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 Tradename: NITHIODOTE

Country Document Number Estimated Expiration
Australia2010213743► subscribe
Japan2012532824► subscribe
European Patent Office2451435► 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: NITHIODOTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/021United Kingdom► subscribePRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
C0041France► subscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
90062-5Sweden► subscribePRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
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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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