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-two 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:	32
US Patents:	6
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	67
Patent Applications:	4,144
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SODIUM THIOSULFATE

Constraining patent/regulatory exclusivity:

9,585,912

NDA:

203923

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.

Recent Clinical Trials for SODIUM THIOSULFATE

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1
The Netherlands Cancer Institute	PHASE3

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.

This potential generic entry date is based on patent 9,585,912.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

When does loss-of-exclusivity occur for SODIUM THIOSULFATE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Denmark

European Patent Office

Hungary

Japan

Norway

Poland

Portugal

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Australia	2010270605
Canada	2767168
Denmark	2451435
European Patent Office	2451435
European Patent Office	3213756

Supplementary Protection Certificates for SODIUM THIOSULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204

Sodium Thiosulfate: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Sodium thiosulfate is an inorganic salt with applications in medicine, photography, and industrial processes. Its pharmaceutical applications are primarily focused on its use as an antidote for cyanide poisoning and as a treatment for calciphylaxis, a rare and severe condition associated with chronic kidney disease. The market for sodium thiosulfate as a pharmaceutical agent is driven by specific clinical needs and its established efficacy in niche indications.

What is the Current Market Size and Growth Projection for Pharmaceutical-Grade Sodium Thiosulfate?

The global market for pharmaceutical-grade sodium thiosulfate is a niche segment within the broader pharmaceutical ingredients market. Accurate, publicly disclosed market size figures for this specific compound are limited due to its specialized applications and the fact that it is often produced by a limited number of manufacturers.

However, an analysis of related markets and its primary indications provides insight. The market for antidotes, particularly for acute toxic exposures, represents a segment with consistent, albeit fluctuating, demand. The global antidote market, which includes agents for opioid overdose, organophosphate poisoning, and cyanide poisoning, was valued at approximately $1.7 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5.5% to reach $2.4 billion by 2027 [1]. Sodium thiosulfate's position within this market is specialized.

Similarly, the calciphylaxis treatment market is exceptionally small but critical for affected patients. Calciphylaxis treatment often involves a multimodal approach, and sodium thiosulfate plays a specific role. The global rare diseases market, of which calciphylaxis treatment is a minuscule part, is significantly larger. The overall rare disease market was valued at over $225 billion in 2022 and is expected to expand considerably [2]. While sodium thiosulfate is not a blockbuster drug, its role in managing calciphylaxis contributes to this broader market by addressing a specific unmet need.

Growth projections for pharmaceutical-grade sodium thiosulfate are likely to be modest, driven by:

• Consistent Demand for Cyanide Antidotes: Emergency preparedness and industrial safety protocols ensure a baseline demand.
• Increasing Diagnosis of Calciphylaxis: While still rare, improved diagnostic capabilities and awareness among nephrologists may lead to a slight increase in utilization.
• Lack of Direct Competitors: For its primary indications, there are few direct therapeutic alternatives.

Given these factors, the annual growth rate for pharmaceutical-grade sodium thiosulfate is estimated to be in the low single digits, likely between 2% and 4%. This is a pragmatic projection, reflecting its established therapeutic roles rather than rapid market expansion.

What are the Primary Pharmaceutical Applications and Their Market Impact?

The pharmaceutical utility of sodium thiosulfate is concentrated in two critical areas:

Cyanide Poisoning Antidote

• Mechanism: Sodium thiosulfate acts as a sulfur donor, converting cyanide (CN-) into the less toxic thiocyanate (SCN-), which is then excreted by the kidneys. This process is catalyzed by the enzyme rhodanese.
• Market Impact: This application drives demand in:
  • Emergency Medical Services: Stockpiled in ambulances, emergency rooms, and hospitals for rapid administration.
  • Industrial Settings: Used in industries where cyanide exposure is a risk (e.g., mining, electroplating, chemical manufacturing).
  • Government Stockpiles: Maintained by public health agencies for disaster preparedness.
• Sales Drivers: Public health initiatives, industrial safety regulations, and preparedness for large-scale poisoning events. The demand is episodic but critical.

Calciphylaxis Treatment

• Mechanism: The exact mechanism is not fully elucidated, but it is believed to involve binding to calcium ions, chelating them, and potentially inhibiting the progression of vascular calcification. It may also have antioxidant properties.
• Market Impact: This application targets a small but severely ill patient population:
  • Nephrology Clinics: Primarily used in patients with end-stage renal disease (ESRD) who develop calciphylaxis.
  • Dermatology and Vascular Surgery: Involved in wound management for skin lesions associated with calciphylaxis.
• Sales Drivers: Prevalence of ESRD, incidence of calciphylaxis among this population, and clinical guidelines recommending its use. This is a more consistent, albeit low-volume, demand compared to acute cyanide poisoning.

Comparison of Market Impact:

Application	Demand Profile	Patient Population	Sales Volume	Sales Value
Cyanide Antidote	Episodic, critical	Acute toxicity	Moderate	Moderate-High
Calciphylaxis Treatment	Consistent, niche	Chronic kidney	Low	Low-Moderate

Note: "Moderate" and "Low" here refer to relative volumes and values within the context of sodium thiosulfate's pharmaceutical use, not the broader pharmaceutical market.

Who are the Key Manufacturers and Suppliers of Pharmaceutical-Grade Sodium Thiosulfate?

The manufacturing landscape for pharmaceutical-grade sodium thiosulfate is characterized by a limited number of established chemical and pharmaceutical ingredient suppliers. These companies typically operate under stringent Good Manufacturing Practices (GMP) to ensure product purity and consistency.

Key players include:

• Merck KGaA (Germany): A diversified science and technology company with a strong presence in performance materials and chemicals.
• Spectrum Chemical Manufacturing Corp. (USA): A supplier of high-purity chemicals and laboratory products, including active pharmaceutical ingredients (APIs).
• Amresco (USA): Provides a range of chemicals and reagents for research and manufacturing, including pharmaceutical-grade products.
• Thermo Fisher Scientific (USA): A global leader in serving science, offering a broad portfolio of chemicals and reagents.
• BASF SE (Germany): A major chemical producer with potential for supplying pharmaceutical intermediates and ingredients.
• Various regional API manufacturers: Particularly in India and China, specialized chemical manufacturers produce GMP-compliant sodium thiosulfate.

Supplier Considerations for Pharmaceutical Companies:

• GMP Compliance: Essential for API sourcing. Audits and regulatory documentation are critical.
• Supply Chain Reliability: Ensuring consistent availability for critical antidotes and chronic treatments.
• Purity and Specifications: Meeting stringent pharmacopeial standards (e.g., USP, EP).
• Cost: While a niche product, competitive pricing remains a factor.

What is the Regulatory Landscape Governing Sodium Thiosulfate for Pharmaceutical Use?

The regulatory framework for pharmaceutical-grade sodium thiosulfate is defined by national and international health authorities. Compliance is mandatory for manufacturers and for the drugs that incorporate it.

Key Regulatory Aspects:

• Active Pharmaceutical Ingredient (API) Registration: Manufacturers of sodium thiosulfate intended for pharmaceutical use must comply with API registration requirements in target markets. This often involves submitting Drug Master Files (DMFs) to regulatory bodies like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
• Pharmacopeial Standards: Sodium thiosulfate must meet the purity and quality specifications outlined in major pharmacopeias, including:
  • United States Pharmacopeia (USP): Defines standards for identity, purity, strength, and quality for drugs marketed in the U.S.
  • European Pharmacopoeia (EP): Sets similar standards for medicines in Europe.
  • Japanese Pharmacopoeia (JP): For products marketed in Japan.
• Good Manufacturing Practices (GMP): Production facilities must adhere to GMP guidelines to ensure consistent quality, safety, and efficacy. Regulatory agencies conduct inspections to verify compliance.
• Indication-Specific Approvals:
  • Cyanide Antidote: While sodium thiosulfate is an established antidote, specific combination products (e.g., containing amyl nitrite, sodium nitrite, and sodium thiosulfate) have undergone regulatory review and approval. Its use as a standalone antidote is also recognized.
  • Calciphylaxis Treatment: Drugs containing sodium thiosulfate for this indication have undergone regulatory approval processes, often as specialized therapies.
• Labeling and Packaging: Requirements include clear identification of the active ingredient, strength, lot number, expiry date, storage conditions, and usage instructions, particularly for emergency use.

Recent Regulatory Developments:

There have been no recent, significant regulatory shifts specifically targeting sodium thiosulfate that would fundamentally alter its market. However, ongoing pharmacopeial updates and evolving GMP enforcement by agencies like the FDA and EMA are continuous. For instance, the FDA's increasing focus on supply chain security and the quality of imported APIs impacts all pharmaceutical ingredients, including sodium thiosulfate.

What are the Key Challenges and Opportunities in the Sodium Thiosulfate Pharmaceutical Market?

The market for pharmaceutical-grade sodium thiosulfate presents a unique set of challenges and opportunities for stakeholders.

Challenges:

• Niche Market Size: The limited number of indications restricts potential revenue growth compared to blockbuster drugs.
• Supply Chain Vulnerability: Reliance on a few key manufacturers can create risks of shortages if production is disrupted.
• Price Sensitivity in Certain Segments: While critical, cost pressures can exist, especially for government stockpiles or in regions with budget constraints.
• Limited R&D Investment: Due to its established nature and niche applications, significant investment in developing new formulations or expanding indications is unlikely.
• Perception as a Commodity Chemical: While pharmaceutical-grade is distinct, the perception of sodium thiosulfate as an industrial chemical can sometimes overshadow its pharmaceutical value.

Opportunities:

• Expanding Calciphylaxis Treatment Protocols: Further clinical research demonstrating improved outcomes or cost-effectiveness could lead to broader adoption.
• Emerging Industrial/Environmental Applications: While not pharmaceutical, any new significant industrial uses that require high-purity grades could indirectly support manufacturing infrastructure.
• Geographic Market Penetration: Increasing access to emergency medical care and specialized nephrology services in developing economies could drive demand.
• Combination Therapies: Exploring synergistic effects with other agents for calciphylaxis or developing novel antidote formulations for cyanide poisoning.
• Supply Chain Resilience: Companies that can ensure robust, reliable, and transparent supply chains for GMP-grade sodium thiosulfate will have a competitive advantage.

What is the Financial Trajectory and Investment Outlook for Sodium Thiosulfate Producers?

The financial trajectory for producers of pharmaceutical-grade sodium thiosulfate is one of stable, albeit modest, revenue generation. The investment outlook is cautious, favoring companies with diversified portfolios and established market positions rather than speculative ventures.

Financial Trajectory:

• Revenue Streams: Primarily driven by contracts with hospitals, emergency medical suppliers, government agencies (for strategic reserves), and potentially pharmaceutical companies developing finished dosage forms.
• Profitability: Profit margins are likely to be steady, influenced by production costs, regulatory compliance expenses, and the competitive pricing among a limited number of GMP suppliers. Gross margins might be in the 30-50% range, typical for specialized APIs.
• Capital Investment: Investment is focused on maintaining GMP-compliant facilities, ensuring quality control, and managing inventory. Significant capital expenditure for capacity expansion is unlikely unless a new, larger application emerges.
• Market Dynamics: The demand is relatively inelastic for its critical applications, providing a baseline of predictable revenue. However, the absence of patent cliffs or significant new drug development means organic growth is slow.

Investment Outlook:

• For Established API Manufacturers: Companies with existing GMP infrastructure and a broad portfolio that includes sodium thiosulfate will see it as a stable, albeit minor, contributor to their overall financials. Investment would focus on optimizing production and maintaining regulatory compliance.
• For Specialty Chemical Companies: Companies that can produce high-purity sodium thiosulfate cost-effectively and secure long-term supply agreements could find it an attractive, stable product line.
• For Pharmaceutical Developers: Investment in sodium thiosulfate as an API is typically linked to the development of a specific drug product. The financial outlook for such investments is tied to the success of that specific therapeutic indication and its market adoption.
• Venture Capital/Private Equity: Unlikely to target sodium thiosulfate as a primary investment focus due to its mature market and limited growth potential. Investment might occur as part of a broader acquisition of a specialty chemical or API manufacturer.

Key Financial Metrics to Monitor:

• Volume Sales Trends: Tracking procurement orders from major buyers.
• Pricing Trends: Monitoring average selling prices across different markets and customer types.
• Regulatory Compliance Costs: An ongoing expenditure that impacts net profit.
• Inventory Management Costs: Balancing supply to meet critical demand without excessive carrying costs.

The financial trajectory is not characterized by rapid growth or dramatic decline, but rather by sustained demand for critical applications. Investment is strategic, focused on reliability and compliance rather than high-risk, high-reward scenarios.

Key Takeaways

• Pharmaceutical-grade sodium thiosulfate serves critical niche markets as a cyanide poisoning antidote and a treatment for calciphylaxis.
• The global market size is not precisely defined but is embedded within the broader antidote and rare disease markets, with modest projected growth (2-4% CAGR).
• Key manufacturers are established API suppliers adhering to strict GMP standards.
• Regulatory oversight focuses on API registration, pharmacopeial compliance, and GMP, with no recent significant shifts specifically for sodium thiosulfate.
• Challenges include limited market size and supply chain vulnerability, while opportunities lie in expanded calciphylaxis treatment and geographic market penetration.
• The financial trajectory for producers is stable and predictable, with a cautious investment outlook focused on established players and supply chain resilience.

FAQs

1. What is the primary mechanism by which sodium thiosulfate treats cyanide poisoning? Sodium thiosulfate acts as a sulfur donor in a process catalyzed by the enzyme rhodanese. It converts highly toxic cyanide ions (CN-) into less toxic thiocyanate ions (SCN-), which are then excreted by the kidneys.

2. Is sodium thiosulfate a widely used drug for calciphylaxis? Sodium thiosulfate is used for calciphylaxis, a rare and severe condition, primarily in patients with end-stage renal disease. While critical for affected individuals, its usage volume is low due to the rarity of the disease.

3. What are the main regulatory requirements for sodium thiosulfate used in pharmaceuticals? Manufacturers must comply with Good Manufacturing Practices (GMP), ensure their product meets pharmacopeial standards (e.g., USP, EP), and may need to file Drug Master Files (DMFs) with regulatory agencies like the FDA.

4. Are there significant patent protections for sodium thiosulfate? Sodium thiosulfate is a well-established inorganic compound, and its basic use as an antidote or for calciphylaxis is not covered by current patents. Patents might exist for specific formulations, combination products, or novel delivery methods.

5. What is the typical supply chain for pharmaceutical-grade sodium thiosulfate? The supply chain typically involves specialized chemical manufacturers producing GMP-grade sodium thiosulfate, which is then supplied to pharmaceutical companies for formulation or directly to healthcare institutions and emergency preparedness organizations.

Citations

[1] Mordor Intelligence. (2023). Antidotes Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). [2] Global Data. (2023). Rare Disease Market Analysis Report.