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Last Updated: December 2, 2022

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium thiosulfate has twenty-six patent family members in twelve countries.

There are two drug master file entries for sodium thiosulfate. One supplier is listed for this compound.

Summary for sodium thiosulfate
International Patents:26
US Patents:4
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 124
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
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

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
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
Fennec Pharms Inc PEDMARK sodium thiosulfate SOLUTION;INTRAVENOUS 212937-001 Sep 20, 2022 RX Yes Yes 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 See Plans and Pricing
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
>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 Title Estimated Expiration
Japan 7166377 See Plans and Pricing
Spain 2655883 See Plans and Pricing
Japan 2012532824 See Plans and Pricing
Hungary E035519 See Plans and Pricing
Japan 6166393 See Plans and Pricing
Japan 6852136 See Plans and Pricing
Canada 2767168 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) 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
2666774 CR 2020 00037 Denmark See Plans and Pricing 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
0806968 SPC/GB07/011 United Kingdom See Plans and Pricing PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
2203431 CA 2015 00014 Denmark See Plans and Pricing PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2822954 SPC/GB18/031 United Kingdom See Plans and Pricing PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2340828 LUC00195 Luxembourg See Plans and Pricing PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0579826 SPC/GB02/042 United Kingdom See Plans and Pricing 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
0145340 99C0005 Belgium See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Dow
Baxter
Colorcon
Medtronic

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