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Sodium thiosulfate - Generic Drug Details
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What are the generic sources for sodium thiosulfate and what is the scope of patent protection?
Sodium thiosulfate
is the generic ingredient in one branded drug marketed by Us Army and Hope Pharms, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium thiosulfate has twenty-two patent family members in eleven countries.
There are one thousand four hundred and seventy-two drug master file entries for sodium thiosulfate. One supplier is listed for this compound.
Summary for sodium thiosulfate
International Patents: | 22 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 1472 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 128 |
Clinical Trials: | 51 |
Patent Applications: | 2,217 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in sodium thiosulfate? | sodium thiosulfate excipients list |
DailyMed Link: | sodium thiosulfate at DailyMed |
Recent Clinical Trials for sodium thiosulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hyunseok Kang, MD | Phase 2 |
NRG Oncology | Phase 2 |
Shanghai Children's Hospital | Phase 3 |
US Patents and Regulatory Information for sodium thiosulfate
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
Us Army | SODIUM THIOSULFATE | sodium thiosulfate | INJECTABLE;INJECTION | 020166-001 | Feb 14, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for sodium thiosulfate
Country | Patent Number | Estimated Expiration |
---|---|---|
Hungary | E035519 | Start Trial |
European Patent Office | 2451435 | Start Trial |
Denmark | 2451435 | Start Trial |
Japan | 2020011992 | Start Trial |
Japan | 2016106110 | Start Trial |
Japan | 2016153360 | Start Trial |
Japan | 6598965 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium thiosulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2822954 | LUC00083 | Luxembourg | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625 |
1499331 | SPC/GB13/034 | United Kingdom | Start Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
1948158 | 1690020-1 | Sweden | Start Trial | PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123 |
1912999 | 1490062-5 | Sweden | Start Trial | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
0290047 | SPC/GB97/078 | United Kingdom | Start Trial | PRODUCT 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 |
0473687 | SPC/GB98/030 | United Kingdom | Start Trial | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
2822954 | 1890030-8 | Sweden | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |