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 twelve 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:	12
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	63
Patent Applications:	4,306
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
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	Phase 1/Phase 2
Xianyang Central Hospital (the second people's Hospital of Xianyang City)	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	2022-10-18
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	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
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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	2019299216	Anhydrous sodium thiosulfate and formulations thereof	⤷ Sign Up
Japan	5905387		⤷ Sign Up
Japan	6598965		⤷ Sign Up
Portugal	2451435		⤷ Sign Up
Australia	2019299217	Formulations of anhydrous sodium thiosulfate	⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020009954		⤷ 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
2563920	CR 2019 00001	Denmark	⤷ Sign Up	PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
1713823	92595	Luxembourg	⤷ Sign Up	PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516
1912999	2014/058	Ireland	⤷ Sign Up	PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
1758590	LUC00029	Luxembourg	⤷ Sign Up	PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
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
2822954	18C1035	France	⤷ Sign Up	PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
0290047	97C0108	Belgium	⤷ Sign Up	PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.