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Last Updated: November 8, 2024

Sodium thiosulfate - Generic Drug Details


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What are the generic drug sources for sodium thiosulfate and what is the scope of patent protection?

Sodium thiosulfate is the generic ingredient in two branded drugs marketed by Us Army, Fennec Pharms Inc, and Hope Pharms, and is included in three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium thiosulfate has sixty-four patent family members in nineteen countries.

There are two drug master file entries for sodium thiosulfate. Two suppliers are listed for this compound.

Summary for sodium thiosulfate
Recent Clinical Trials for sodium thiosulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Pontificia Universidad Catolica de ChilePhase 1/Phase 2
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)Phase 1/Phase 2
Xianyang Central Hospital (the second people's Hospital of Xianyang City)N/A

See all sodium thiosulfate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for sodium thiosulfate
Paragraph IV (Patent) Challenges for SODIUM THIOSULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PEDMARK Intravenous Injection sodium thiosulfate 12.5 g/100 mL 212937 1 2022-10-18
PEDMARK Intravenous Injection sodium thiosulfate 12.5 g/100 mL 212937 1 2022-10-07
SODIUM THIOSULFATE Intravenous Injection sodium thiosulfate 12.5 g/50 mL 203923 1 2022-04-29

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Us Army SODIUM THIOSULFATE sodium thiosulfate INJECTABLE;INJECTION 020166-001 Feb 14, 1992 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for sodium thiosulfate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Fennec Pharmaceuticals (EU) Limited Pedmarqsi sodium thiosulfate EMEA/H/C/005130
Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.
Authorised no no no 2023-05-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for sodium thiosulfate

Country Patent Number Title Estimated Expiration
European Patent Office 3818010 THIOSULFATE DE SODIUM ANHYDRE ET FORMULATIONS DE CELUI-CI (ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF) ⤷  Sign Up
Israel 274645 שיטה להפחתת אוטוטוקסיות בילדים חולים המקבלים כימותרפיה מבוסס פלטינום (Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy) ⤷  Sign Up
Norway 2451435 ⤷  Sign Up
South Korea 20210027410 무수 싸이오황산나트륨의 제형 ⤷  Sign Up
Mexico 2020013734 FORMULACIONES DE TIOSULFATO DE SODIO ANHIDRO. (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE.) ⤷  Sign Up
Japan 2021107318 チオ硫酸ナトリウムを含有する薬学的組成物 (PHARMACEUTICAL COMPOSITION CONTAINING SODIUM THIOSULFATE) ⤷  Sign Up
Hungary E035519 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium thiosulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1856135 SPC/GB20/016 United Kingdom ⤷  Sign Up PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
2666774 CR 2020 00037 Denmark ⤷  Sign Up PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217
2932970 18C1043 France ⤷  Sign Up PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2673237 1990016-6 Sweden ⤷  Sign Up PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
1175904 2007C/048 Belgium ⤷  Sign Up PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2203431 92666 Luxembourg ⤷  Sign Up PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
0579826 SPC/GB02/042 United Kingdom ⤷  Sign Up PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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