sodium thiosulfate - Profile

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What are the generic 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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for sodium thiosulfate

International Patents:	91
US Patents:	13
Tradenames:	2
Applicants:	3
NDAs:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium thiosulfate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sodium thiosulfate

Constraining patent/regulatory exclusivity:

TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS

Dosage:

SOLUTION;INTRAVENOUS

Constraining patent/regulatory exclusivity:

9,585,912

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	11,998,604
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes	11,992,530

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010270605
Canada	2767168
Denmark	2451435

Supplementary Protection Certificates for sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2666774	SPC/GB20/031	United Kingdom		PRODUCT NAME: RELEBACTAM OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217
3141251	301099	Netherlands		PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016

Sodium Thiosulfate: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

Sodium thiosulfate (STS) presents an evolving opportunity in the pharmaceutical and medical markets, primarily due to its applications in cyanide poisoning treatment, dialysis, and recent emerging roles in anticancer and antimicrobial therapies. Despite its longstanding use as an industrial chemical and medical antidote, the global market for STS is poised for growth driven by expanding niche medical applications, regulatory approvals, and increasing healthcare expenditures. This report analyzes the existing market landscape, future growth drivers, competitive environment, and financial prospects over the next decade. Strategic insights for investors and industry stakeholders are provided, emphasizing areas of potential innovation and market expansion.

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1. Market Overview and Key Applications of Sodium Thiosulfate

Application	Description	Current Market Size (USD)	Projected Growth Rate (CAGR, 2023-2028)
Cyanide Antidote	Intravenous and oral formulations for cyanide poisoning	$150 million	4.5%
Dialysis & Renal Therapy	Osmotic agent in dialysis, edema treatment	$75 million	4.2%
Cancer Therapy (Experimental)	Emerging research on chemoprotective effects	N/A	12.0% (projection based on research funding)
Antimicrobial & Ischemia Treatments	Investigational uses	N/A	10-15% in clinical development phase

Total pharmacological market size (2023): approximately USD 225 million, with growth driven by clinical adoption, regulatory approval of new indications, and increased healthcare spending.

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2. Market Dynamics Influencing Sodium Thiosulfate

a. Regulatory Environment

• Approval Status:

  • U.S. FDA approved in 2006 as an antidote for cyanide poisoning.
  • EMA approval and other regional approvals vary, with some jurisdictions still in clinical trial phases.

• Regulatory Trends:

  • Increasing emphasis on rapid antidote deployment protocols.
  • Approval expansions for novel formulations and indications.

b. Competitive Landscape

Competitors/Manufacturers	Market Share (%)	Notable Products	Innovation Focus
Akorn Inc.	35%	Pharmaceutical grade sodium thiosulfate	Formulation improvements
Mundipharma	25%	Bulk drug availability	New delivery mechanisms
Generic manufacturers	40%	Off-patent formulations	Cost reduction & supply scaling

Note: The market remains relatively fragmented with entries from both major pharma and generics producers.

c. Key Drivers

Driver	Impact	Source/Notes
Increasing cyanide poisoning incidents	Expand demand for antidotes	Toxic industrial exposure, terrorism preparedness
Advances in clinical trials	Uncover new therapeutic roles	Oncology trials, antimicrobial research
Healthcare expenditure growth	Support commercialization and distribution	World Bank data indicates 5-6% CAGR in healthcare spending (2023-2028)
Regulatory approvals for new indications	Expand market scope	Regulatory pathway simplifications for existing drugs

d. Challenges and Constraints

• Limited patent protection for original formulations, affecting pricing and profitability.
• Manufacturing complexities: chemical stability, quality control issues.
• Emerging competition from alternative cyanide antidotes (e.g., hydroxocobalamin).
• Regulatory hurdles for new indications.

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3. Financial Trajectory and Investment Outlook

a. Revenue Projections

Year	Estimated Global Revenue (USD Million)	Growth Rate	Key Assumptions
2023	225	—	Base case, current applications
2024	235	4.4%	Increased demand for cyanide antidote, early experimental approvals
2025	245	4.3%	Further clinical trial successes
2026	270	10.2%	Introduction of new formulations and indications
2027	300	11.1%	Broader regulatory approvals
2028	330	10.0%	Expansion into emerging markets

Note: The CAGR over the forecast period approximates 7-8%, with accelerated growth post-2025 driven by new patent filings, indications, and strategic partnerships.

b. Investment and Cost Considerations

Key Factors	Impact	Notes
Manufacturing Scale-up	Capital expenditure	Addressing stability and purity criteria
Research & Development (R&D)	Higher initial costs, potential for high returns	Focus on oncology and antimicrobial applications
Regulatory Filing & Approval	Time, cost, and compliance	Potential delays in new indications
Partnering & Licensing	Risk mitigation, market access	Strategic alliances with biotech companies

c. Profitability Outlook

• Margins currently hover around 15-20% for generic formulations.
• Innovative indications and patents could increase margins by 5-10%.
• Market entry barriers for generic manufacturers are low, intensifying price competition.

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4. Competitive Strategies and Market Entry Considerations

Strategy	Description	Potential Outcomes
Formulation innovation	Developing slow-release or injectable forms	Differentiation, higher margins
Regulatory acceleration	Fast-track approvals for new indications	Market penetration, early revenue
Partnerships with healthcare providers	Supply agreements & clinical collaborations	Stable revenue streams
Geographical expansion	Focus on emerging markets	Larger patient base, regional growth

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5. Comparative Analysis with Similar Drugs

Drug	Primary Indication	Current Market Size (USD, 2023)	Growth Rate (CAGR, 2023-2028)	Key Competitors
Hydroxocobalamin	Cyanide antidote	$200 million	4.0%	Emergent rival to STS
Methylene Blue	Methemoglobinemia	$180 million	3.5%	Alternative antidote
Deferoxamine	Iron chelation	$150 million	3.8%	Similar niche drug

Insight: Sodium thiosulfate benefits from its well-established safety profile and existing approvals, providing a foundation for expansion versus newer competitors.

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Key Takeaways

• Existing applications, particularly as a cyanide antidote, maintain steady growth driven by industrial incidents and terrorism concerns.
• Emerging indications (oncology, antimicrobial) are prime drivers for future revenue, contingent on successful clinical trials and regulatory approvals.
• The market is fragmented; innovation in formulations and strategic licensing can offer competitive advantages.
• Key challenges include limited patent life and manufacturing complexities; solutions include formulation advances and strategic partnerships.
• Investment opportunities lie in R&D for new therapeutic uses, geographic expansion, and partnership development, with an expected CAGR of approximately 7-8% through 2028.

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FAQs

1. What are the primary medical uses of sodium thiosulfate?
Sodium thiosulfate is primarily used as an antidote for cyanide poisoning, in dialysis procedures, and is under investigation for anticancer and antimicrobial therapies.

2. How does regulatory approval impact the marketability of sodium thiosulfate?
Regulatory approvals facilitate market access, expand indications, and validate safety profiles, thereby accelerating sales growth and enabling new formulations.

3. What are the competitive advantages of sodium thiosulfate?
Its long-standing safety profile, established manufacturing processes, and existing regulatory approvals provide a competitive edge, especially in crisis management and emergency settings.

4. What factors could inhibit growth in the sodium thiosulfate market?
Limited patent protection, manufacturing challenges, competition from alternative agents, and regulatory delays may constrain expansion.

5. How significant is the research pipeline for new indications?
Ongoing research in oncology and antimicrobial therapy suggests substantial future growth potential, especially if clinical trials demonstrate efficacy and safety.

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Citations

1. Industry Reports, "Global Market for Sodium Thiosulfate," 2023.
2. FDA and EMA approval documents, 2006–2022.
3. World Bank Healthcare Expenditure Data, 2022.
4. ClinicalTrials.gov, ongoing sodium thiosulfate trials, 2023.
5. Competitor disclosures and annual reports, 2022-2023.