SODIUM THIOSULFATE Drug Patent Profile

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 five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight 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. Two suppliers are 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 14^th, 2012.

Summary for SODIUM THIOSULFATE

International Patents:	28
US Patents:	5
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	60
Patent Applications:	2,959
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

SODIUM THIOSULFATE is protected by five US patents.

Patents protecting SODIUM THIOSULFATE

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
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
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

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

Country	Patent Number	Title	Estimated Expiration
Spain	2655883
Japan	2023015121	チオ硫酸ナトリウムを含有する薬学的組成物
European Patent Office	2451435	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	2019048852	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)
Japan	6166393

Supplementary Protection Certificates for SODIUM THIOSULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0806968	SPC/GB07/011	United Kingdom		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
1499331	SPC/GB13/034	United Kingdom		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	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
2822954	SPC/GB18/031	United Kingdom		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
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518