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Generated: July 20, 2017
What are the generic sources for sodium thiosulfate and what is the scope of sodium thiosulfate patent protection?
Sodium thiosulfate is the generic ingredient in one branded drug marketed by Hope Pharms and Us Army, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 4 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 1392 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 50 |
| Clinical Trials: see list | 2,355 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | sodium thiosulfate 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 | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | 9,585,912 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Us Army | SODIUM THIOSULFATE | sodium thiosulfate | INJECTABLE;INJECTION | 020166-001 | Feb 14, 1992 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | 8,496,973 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | 9,345,724 | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,715,746 | Sodium thiosulfate-containing pharmaceutical compositions | ► Subscribe | |||||||||||||||||||||||||||
| 9,579,345 | Sodium thiosulfate-containing pharmaceutical compositions | ► Subscribe | |||||||||||||||||||||||||||
| 9,144,580 | Sodium 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2451435 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2012532824 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 2016106110 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2010270605 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 2011005841 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0005 | Belgium | ► Subscribe | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 | ||||||||||||||||||||||||||
| 90018-6 | Sweden | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 | ||||||||||||||||||||||||||
| 666 | Luxembourg | ► Subscribe | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 | ||||||||||||||||||||||||||
| C0041 | France | ► Subscribe | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 | ||||||||||||||||||||||||||
| 2015 00014 | Denmark | ► Subscribe | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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