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Last Updated: March 29, 2024

sodium thiosulfate Drug Patent 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 five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven 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. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.

DrugPatentWatch® 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.

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Drug patent expirations by year for sodium thiosulfate
Recent Clinical Trials for sodium thiosulfate

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

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

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 2022-10-07
SODIUM THIOSULFATE Intravenous Injection sodium thiosulfate 12.5 g/50 mL 203923 1 2022-04-29

US Patents and Regulatory Information for sodium thiosulfate

sodium thiosulfate is protected by five US patents.

Patents protecting sodium thiosulfate

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Us Army SODIUM THIOSULFATE sodium thiosulfate INJECTABLE;INJECTION 020166-001 Feb 14, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y 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

International Patents for sodium thiosulfate

See the table below for patents covering sodium thiosulfate around the world.

Country Patent Number Title Estimated Expiration
Hungary E035519 ⤷  Try a Trial
Japan 2019048852 チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Japan 6598965 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for sodium thiosulfate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0579826 SPC/GB02/042 United Kingdom ⤷  Try a Trial 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
1499331 SPC/GB13/034 United Kingdom ⤷  Try a 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
0480717 98C0022 France ⤷  Try a Trial PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
>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.