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 six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-one 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:	31
US Patents:	6
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	66
Patent Applications:	4,099
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
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	PHASE2

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

SODIUM THIOSULFATE is protected by six US patents.

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	12,304,813		Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	10,479,686		Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	9,345,724		Y	Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes	8,496,973		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/005130Pedmarqsi 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
Japan	2017165758
Japan	7629976
Japan	6438071
Japan	2023015121	チオ硫酸ナトリウムを含有する薬学的組成物
Japan	7408753

Supplementary Protection Certificates for SODIUM THIOSULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2673237	SPC/GB19/027	United Kingdom		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REGISTERED: UK EU/1/17/1173(NI) 20180326; UK PLGB17901/0331-0001 20180326; UK PLGB17902/0332-0001 20180326
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115
2666774	LUC00167	Luxembourg		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

Market Dynamics and Financial Trajectory for Sodium Thiosulfate

Last updated: July 29, 2025

Introduction

Sodium thiosulfate (STS), a versatile inorganic compound with the chemical formula Na₂S₂O₃, has historically been associated with medical applications, industrial processes, and environmental remediation. Its primary medical use is as an antidote for cyanide poisoning, while industrial applications include photographic fixing, water treatment, and chemical manufacturing. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of sodium thiosulfate becomes critical for stakeholders including manufacturers, investors, healthcare providers, and policymakers.

This analysis explores the current market forces influencing sodium thiosulfate, ongoing research and development (R&D) factors, competitive landscape, regulatory environment, and financial forecasts, emphasizing the compound’s future growth potential.

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Market Overview

Current Applications

Medical Use:
Sodium thiosulfate is widely recognized for its role as an antidote in cyanide poisoning, especially in emergency medicine settings and military applications. Additionally, it is used in treating calciphylaxis, a rare but serious complication of end-stage renal disease, and in certain chemotherapeutic protocols to mitigate toxicity.

Industrial Uses:
In industries, STS functions as a photographic fixer, dechlorinating agent in water treatment, and as a reagent in chemical synthesis. Its role in environmental decontamination and mining processes, such as gold extraction, also signifies its industrial importance.

Emerging Pharmaceutical Indications:
Recent preclinical studies and clinical trials explore sodium thiosulfate's potential in managing radiotherapy-induced ototoxicity, reducing oxidative stress, and as an adjunct in certain cancer therapies, hinting at expanding therapeutic avenues.

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Market Dynamics

Drivers

Increasing Incidence of Cyanide Poisoning and Emergencies
Global incidents involving cyanide exposure, whether due to industrial accidents, terrorist activities, or military conflicts, sustain demand for effective antidotes like sodium thiosulfate [1]. Emergency preparedness and rapid response protocols bolster its medical application.

Growing R&D and Clinical Investigations
Recent research into novel therapeutic applications enhances sodium thiosulfate's profile. For instance, clinical trials indicating its efficacy in reducing chemotherapy-induced hearing loss or as a potential neuroprotective agent are catalysts for future demand.

Regulatory Approvals and Healthcare Infrastructure
Regulatory bodies’ approval of sodium thiosulfate for specific indications, combined with expanding healthcare infrastructure in developing economies, broadens access and usage.

Industrial Expansion and Environmental Regulations
Increasing industrial activity, especially in refining and mining sectors, sustains industrial demand. Stringent environmental standards for water treatment and chemical processing further incentivize its use.

Challenges

Availability of Alternatives
Emerging alternatives such as hydroxocobalamin—which also serves as a cyanide antidote—may impact sodium thiosulfate's dominance in certain markets [2].

Supply Chain Constraints
Limited manufacturing capacity and raw material fluctuations can cause supply disruptions, affecting pricing and availability.

Regulatory Hurdles
Divergent regulatory landscapes and approval processes across regions delay market entry and expansion.

Market Awareness and Education
Insufficient awareness among healthcare providers about sodium thiosulfate's full potential, especially for new indications, constrains growth.

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Competitive Landscape

Major players include Crescent Chemicals, Sigma-Aldrich (Merck), Fisher Scientific, and regional suppliers. These companies focus on manufacturing high-purity sodium thiosulfate for medical, industrial, and laboratory applications. Strategic collaborations, patent filings, and R&D investments aim to expand therapeutic indications and improve formulation stability.

Emerging biotech companies are investigating nanoparticle formulations and combination therapies involving sodium thiosulfate, potentially reshaping the competitive landscape in niche markets.

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Regulatory Environment

Sodium thiosulfate's approval as an antidote (e.g., under the US FDA’s Office of Emergency Preparedness) ensures its emergency medical scope. However, approvals for new indications require rigorous clinical evidence and regulatory submissions. Variations in regulatory frameworks across regions influence market penetration.

Innovation approvals and inclusion in treatment guidelines, especially in developing countries, will be pivotal to expanding usage. Industry stakeholders must navigate complex regulatory pathways to introduce novel formulations and indications.

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Financial Trajectory and Market Forecast

Historical Market Performance

The global sodium thiosulfate market was valued at approximately $150 million in 2022, driven predominantly by medical application sales. Industrial segments contribute a substantial portion, especially in water treatment and photographic applications.

Projected Growth and Trends

The compound's market is anticipated to grow at a compound annual growth rate (CAGR) of 4-6% through 2030, reaching approximately $230-$250 million [3]. Key growth drivers include:

• Expansion of emergency healthcare systems.
• Increased industrial activity in emerging economies.
• R&D leading to new therapeutic indications.
• Adoption in environmental decontamination and mining sectors.

Segment Analysis

• Medical Segment: Expected to dominate the market, with growth propelled by emergency applications and expanding indications like radiotherapy-related ototoxicity.
• Industrial Segment: Steady growth aligned with infrastructure development, particularly in water treatment and chemical manufacturing regions.

Regional Outlook

• North America: Largest market share, driven by advanced healthcare infrastructure and emergency preparedness.
• Europe: Significant due to stringent environmental regulations and industrial demand.
• Asia-Pacific: Fastest-growing region, fueled by industrialization, urbanization, and increasing healthcare access.

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Future Opportunities and Strategic Considerations

1. Drug Development and Repurposing:
   Focused R&D on new indications—such as neuroprotection, ischemia, and oxidative stress modulation—can unlock additional value.

2. Formulation Innovations:
   Development of stable, injectable formulations suitable for emergency settings can increase adoption.

3. Regulatory Approvals for New Uses:
   Navigating pathway approvals in emerging markets can substantially expand revenue streams.

4. Partnerships and Collaborations:
   Alliances with biotech firms, healthcare agencies, and industrial players can facilitate market penetration.

5. Supply Chain Optimization:
   Ensuring raw material security and manufacturing scalability will mitigate risks and improve profit margins.

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Key Takeaways

• Diverse Applications: Sodium thiosulfate remains vital in emergency medicine, chemistry, and environmental industries, with ample scope for expansion into new therapeutic domains.
• Modest but Steady Growth: The market is projected to grow modestly at 4-6% CAGR through 2030, underpinned by increasing demand for cyanide antidotes and industrial applications.
• Regulatory and R&D Influence: Successful navigation of regulatory pathways and active R&D efforts are critical for expanding its therapeutic indications and market share.
• Regional Dynamics: North America and Europe lead in application adoption, while Asia-Pacific presents rapid growth opportunities.
• Strategic Focus: Companies should prioritize formulation innovation, targeted clinical trials for new indications, and regional regulatory strategies to maximize market potential.

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FAQs

1. What are the primary medical indications for sodium thiosulfate?
Sodium thiosulfate is primarily used as an antidote for cyanide poisoning, and it also treats calciphylaxis and mitigates toxicity from certain chemotherapeutic agents [4].

2. How does sodium thiosulfate compare to hydroxocobalamin in cyanide poisoning?
While both are antidotes, hydroxocobalamin is gaining popularity due to faster onset and easier administration, potentially impacting sodium thiosulfate demand in certain markets [2].

3. Are there emerging therapeutic uses for sodium thiosulfate?
Yes, ongoing research investigates its neuroprotective effects, potential in reducing oxidative stress, and as an adjunct in cancer therapy, which could diversify demand sources.

4. What are the main challenges facing sodium thiosulfate’s market growth?
Challenges include competing antidotes, supply chain issues, regulatory delays, and limited awareness of its expanding therapeutic potential.

5. Which regions are most promising for sodium thiosulfate market growth?
The Asia-Pacific region offers high growth potential due to industrialization and expanding healthcare infrastructure, alongside stable markets in North America and Europe.

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References

[1] World Health Organization. "Guidelines for Chemical Emergency Management." 2021.
[2] Rosen, M., et al. "Comparison of cyanide antidotes: hydroxocobalamin vs. sodium thiosulfate." Journal of Toxicology, 2020.
[3] Market Research Future. "Sodium Thiosulfate Market Trends & Forecasts." 2022.
[4] Ahmad, S., et al. “Therapeutic Applications of Sodium Thiosulfate,” International Journal of Pharmacology, 2021.