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SODIUM THIOSULFATE Drug Profile

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Which patents cover Sodium Thiosulfate, and what substitute generic drugs are available?

Sodium Thiosulfate is a drug marketed by Hope Pharms and Us Army and is included in two NDAs. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

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

Summary for Tradename: SODIUM THIOSULFATE

Patents:1
Applicants:2
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list50
Clinical Trials: see list919
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SODIUM THIOSULFATE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hope Pharms
SODIUM THIOSULFATE
sodium thiosulfate
SOLUTION;INTRAVENOUS203923-001Feb 14, 2012RXYesYes8,496,973► SubscribeYY ► Subscribe
Hope Pharms
SODIUM THIOSULFATE
sodium thiosulfate
SOLUTION;INTRAVENOUS203923-001Feb 14, 2012RXYesYes► Subscribe► Subscribe
Us Army
SODIUM THIOSULFATE
sodium thiosulfate
INJECTABLE;INJECTION020166-001Feb 14, 1992DISCNNoNo► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: SODIUM THIOSULFATE

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
9,144,580Sodium thiosulfate-containing pharmaceutical compositions► Subscribe
9,345,724Sodium thiosulfate-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 THIOSULFATE

Country Document Number Estimated Expiration
Japan2012532824► Subscribe
Canada2767168► Subscribe
Japan2016153360► Subscribe
Australia2010270605► Subscribe
Japan2016106110► 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 THIOSULFATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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/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
C0005Belgium► SubscribePRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
C0055France► SubscribePRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: 434323 20130220
595Luxembourg► SubscribePRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
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