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Last Updated: March 28, 2024

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

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

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

Recent Clinical Trials for sodium thiosulfate

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

SponsorPhase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2
Yunnan Cancer HospitalPhase 2
Qilu Hospital of Shandong UniversityPhase 2

See all sodium thiosulfate clinical trials

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 2022-10-07
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
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Supplementary Protection Certificates for sodium thiosulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 2015/009 Ireland ⤷  Try a Trial PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1874117 2014/032 Ireland ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2822954 2018/031 Ireland ⤷  Try a Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.