Sodium thiosulfate - Generic Drug Details

What are the generic drug 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-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

Anatomical Therapeutic Chemical (ATC) Classes for sodium thiosulfate

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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			Y
Us Army	SODIUM THIOSULFATE	sodium thiosulfate	INJECTABLE;INJECTION	020166-001	Feb 14, 1992		DISCN	Yes	No
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes			Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y

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

International Patents for sodium thiosulfate

Country	Patent Number	Title	Estimated Expiration
Japan	7166377
Japan	6438071
Brazil	112021000021	tiossulfato de sódio anidro e formulações do mesmo
Morocco	53102	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE
Canada	2767168	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
European Patent Office	3716987	PROCÉDÉ DE RÉDUCTION DE L'OTOTOXICITÉ CHEZ DES PATIENTS PÉDIATRIQUES RECEVANT UNE CHIMIOTHÉRAPIE À BASE DE PLATINE (METHOD FOR REDUCING OTOTOXICITY IN PEDIATRIC PATIENTS RECEIVING PLATINUM-BASED CHEMOTHERAPY)
Hungary	E035519

Supplementary Protection Certificates for sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
1948158	16C0018	France		PRODUCT NAME: SACUBITRIL/VALSARTAN,SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN,C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL) PROPIONATE-(S)-3'-METHYL-2'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123
2666774	CA 2020 00037	Denmark		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
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0579826	SPC/GB02/042	United Kingdom		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
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725