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Last Updated: June 29, 2022

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 three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four 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. One supplier is 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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Summary for SODIUM THIOSULFATE
International Patents:24
US Patents:3
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 120
Clinical Trials: 57
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
Drug patent expirations by year for SODIUM THIOSULFATE
Recent Clinical Trials for SODIUM THIOSULFATE

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

SponsorPhase
Hellenic Institute for the Study of SepsisPhase 2
Sunnybrook Health Sciences CentrePhase 2
Byondis B.V.Phase 1/Phase 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
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 three US patents.

Patents protecting SODIUM THIOSULFATE

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING

Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Hope Pharms SODIUM THIOSULFATE sodium thiosulfate SOLUTION;INTRAVENOUS 203923-001 Feb 14, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

See the table below for patents covering SODIUM THIOSULFATE around the world.

Country Patent Number Title Estimated Expiration
Japan 2020011992 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) See Plans and Pricing
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) See Plans and Pricing
Japan 6598965 See Plans and Pricing
Japan 6182622 See Plans and Pricing
Japan 6852136 See Plans and Pricing
Portugal 2451435 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SODIUM THIOSULFATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1259550 08C0052 France See Plans and Pricing PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1666481 17C1031 France See Plans and Pricing PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
2203431 2015/009 Ireland See Plans and Pricing PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
2380576 SPC/GB20/050 United Kingdom See Plans and Pricing PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2203431 92666 Luxembourg See Plans and Pricing PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2822954 2018/031 Ireland See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Johnson and Johnson
Merck
Moodys
Mallinckrodt

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