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SODIUM THIOSULFATE Drug Profile
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Which patents cover Sodium Thiosulfate, and what generic alternatives are available?
Sodium Thiosulfate is a drug marketed by Us Army and Hope Pharms and is included in two NDAs. There are three patents protecting this drug.
This drug has twenty-two patent family members in eleven countries.
The generic ingredient in SODIUM THIOSULFATE is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium thiosulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Sodium Thiosulfate
A generic version of SODIUM THIOSULFATE was approved as sodium thiosulfate by HOPE PHARMS on February 14th, 2012.
Summary for SODIUM THIOSULFATE
International Patents: | 22 |
US Patents: | 3 |
Applicants: | 2 |
NDAs: | 2 |
Bulk Api Vendors: | 128 |
Clinical Trials: | 50 |
Patent Applications: | 2,217 |
Formulation / Manufacturing: | see details |
DailyMed Link: | SODIUM THIOSULFATE at DailyMed |

Recent Clinical Trials for SODIUM THIOSULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NRG Oncology | Phase 2 |
Hyunseok Kang, MD | Phase 2 |
Children's Hospital of Fudan University | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | ||
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 |
---|---|---|
Japan | 2019048852 | Start Trial |
European Patent Office | 3213756 | Start Trial |
Japan | 6182622 | Start Trial |
Canada | 2767168 | Start Trial |
Hungary | E035519 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM THIOSULFATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0290047 | 97C0108 | Belgium | Start Trial | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 |
1912999 | 14C0076 | France | Start Trial | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
2822954 | 2018/031 | Ireland | Start Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
0268956 | 1999C0030 | Belgium | Start Trial | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
1856135 | 2090014-8 | Sweden | Start Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |