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Last Updated: May 19, 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 freedom to operate?

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-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

International Patents:	64
US Patents:	9
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	60
Patent Applications:	4,306
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SODIUM THIOSULFATE
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

Sponsor	Phase
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 2
Yunnan Cancer Hospital	Phase 2
Qilu Hospital of Shandong University	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

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Glossary

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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				⤷ 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
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

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2451435	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
Poland	2451435		⤷ Try a Trial
Japan	2021504401	白金ベースの化学療法を受けている小児患者における聴覚毒性を低減するための方法	⤷ Try a Trial
Portugal	2451435		⤷ Try a Trial
Hungary	E035519		⤷ Try a Trial
European Patent Office	3817751	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SODIUM THIOSULFATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0290047	97C0108	Belgium	⤷ Try a Trial	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
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
2932970	1890039-9	Sweden	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1758590	LUC00029	Luxembourg	⤷ Try a Trial	PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
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
2380576	SPC/GB20/050	United Kingdom	⤷ Try a Trial	PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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