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Sodium thiosulfate - Generic Drug Details

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What are the generic sources for sodium thiosulfate and what is the scope of freedom to operate?

Sodium thiosulfate is the generic ingredient in one branded drug marketed by Us Army and Hope Pharms, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium thiosulfate has twenty-one patent family members in eleven countries.

There are one thousand four hundred and seventy-two drug master file entries for sodium thiosulfate. One supplier is listed for this compound.

Summary for sodium thiosulfate

International Patents:	21
US Patents:	3
Tradenames:	1
Applicants:	2
NDAs:	2
Drug Master File Entries:	1472
Suppliers / Packagers:	1
Bulk Api Vendors:	99
Clinical Trials:	45
Patent Applications:	2,217
Formulation / Manufacturing:	see details
DailyMed Link:	sodium thiosulfate at DailyMed

Recent Clinical Trials for sodium thiosulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Early Phase 1
Mayo Clinic	Early Phase 1
Russian Society of Colorectal Surgeons	N/A

See all sodium thiosulfate clinical trials

Synonyms for sodium thiosulfate

10102-17-7 (pentahydrate)

1374442-73-5

13773-27-8

220945-47-1

7772-98-7

AC1L2NGO

AC1Q1USN

ACMC-1BLMJ

AI3-01237

AKHNMLFCWUSKQB-UHFFFAOYSA-L

AKOS015856704

AKOS016372312

anhydrous sodium thiosulfate

BP-21059

CHEBI:132112

CHEMBL3753202

Chlorine Control

Chlorine Cure

CTK2H7219

Declor-It

disodium sulfurothioate

Disodium thiosulfate

DTXSID9042417

EC 231-867-5

EINECS 231-867-5

FT-0696570

HSDB 592

Hypo

Hypo (VAN)

Hypo alcohol

Hypo alcohol, in ethanol

Hyposulphite of soda

I14-16584

KS-00000VC8

KSC377E1T

L0IYT1O31N

LS-153406

MFCD00003499

MolPort-003-926-155

MolPort-006-118-733

Na2O3S2

Na2S2O3

NSC 45624

RP22166

RTR-031296

SC-74795

Sodium oxide sulfide

Sodium oxide sulfide (Na2S2O3)

sodium sulfothioate

sodium thio-sulfate

sodium thiosulfat

sodium thiosulfate (anhydrous)

Sodium thiosulfate (Na2S2O3)

Sodium thiosulfate 2.5M solution (+/- 0.1M) pH 7.0 - 9.0 (Sodium carbonate added as a preservative)

Sodium thiosulfate anhydrous

Sodium thiosulfate concentrate

Sodium thiosulfate solution, 0.01 M

Sodium thiosulfate solution, 0.025 M

Sodium thiosulfate solution, 0.1 M

Sodium thiosulfate solution, 1 M

Sodium thiosulfate solution, 2 g/dL in deionized water

Sodium thiosulfate solution, Silver stain kit component, 0.5 % (w/v) sodium thiosulfate in H2O

Sodium thiosulfate, >=99.99% trace metals basis

Sodium thiosulfate, 0.1 N standard solution

Sodium Thiosulfate, 0.1N Volumetric Solution

Sodium thiosulfate, 98.5%, extra pure, anhydrous

Sodium thiosulfate, 99%, for analysis, anhydrous

Sodium thiosulfate, anhydrous

Sodium thiosulfate, anhydrous, >=98% (calc. to the dried substance)

Sodium thiosulfate, anhydrous, Trace metals grade 99.99%

Sodium thiosulfate, AR, >=98%

Sodium thiosulfate, LR, >=97%

Sodium thiosulfate, p.a., 98.0%

Sodium thiosulfate, purum p.a., anhydrous, >=98.0% (RT)

Sodium thiosulfate, ReagentPlus(R), 99%

Sodium thiosulfate, SAJ first grade, >=90.0%

Sodium thiosulfate, Vetec(TM) reagent grade, 99%

Sodium thiosulfate,anhydrous

Sodium thiosulphate

Sodium thiosulphate (Na2S2O3)

sodiumthiosulfate

Thiosulfuric acid (H2S2O3) disodium salt

Thiosulfuric acid (H2S2O3), disodium salt

Thiosulfuric acid (H2S2O3), sodium salt (1:2)

Thiosulfuric acid, disodium salt

TR-031296

TRA0058020

UNII-L0IYT1O31N

X5843

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
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Us Army	SODIUM THIOSULFATE	sodium thiosulfate	INJECTABLE;INJECTION	020166-001	Feb 14, 1992		DISCN	No	No
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

International Patents for sodium thiosulfate

Country	Patent Number	Estimated Expiration
Japan	6182622
Japan	2012532824
Hungary	E035519
Japan	2019048852
Japan	5905387
Spain	2655883

Supplementary Protection Certificates for sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
2932970	1890039-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
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