Sodium thiosulfate - Generic Drug Details

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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 ten 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:	10
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	62
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
Xianyang Central Hospital (the second people's Hospital of Xianyang City)	N/A
Ankang Central Hospital	N/A
Xi'an International Medical Center Hospital	N/A

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

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Us Army	SODIUM THIOSULFATE	sodium thiosulfate	INJECTABLE;INJECTION	020166-001	Feb 14, 1992		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Australia	2019299217	Formulations of anhydrous sodium thiosulfate	⤷ Sign Up
Poland	2451435		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020009953		⤷ Sign Up
Norway	2451435		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2019108592		⤷ Sign Up
Morocco	53102	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE	⤷ Sign Up
>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
2822954	2018/031	Ireland	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0788511	SPC/GB08/036	United Kingdom	⤷ Sign Up	PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1499331	SPC/GB13/034	United Kingdom	⤷ Sign Up	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
1175904	2007C/048	Belgium	⤷ Sign Up	PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2822954	SPC/GB18/031	United Kingdom	⤷ Sign Up	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
2666774	LUC00167	Luxembourg	⤷ Sign Up	PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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