Sodium nitrite; sodium thiosulfate - Generic Drug Details

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

Sodium nitrite; sodium thiosulfate is the generic ingredient in one branded drug marketed by Hope Pharms and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium nitrite; sodium thiosulfate has sixty-one patent family members in sixteen countries.

One supplier is listed for this compound.

Summary for sodium nitrite; sodium thiosulfate

International Patents:	61
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium nitrite; sodium thiosulfate
DailyMed Link:	sodium nitrite; sodium thiosulfate at DailyMed

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

Dosage:

SOLUTION, SOLUTION;INTRAVENOUS, 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.

Anatomical Therapeutic Chemical (ATC) Classes for sodium nitrite; sodium thiosulfate

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for sodium nitrite; 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	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y

International Patents for sodium nitrite; sodium thiosulfate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3213756	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
European Patent Office	2395834	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	2021107318
Poland	2451435
Portugal	3569237

Supplementary Protection Certificates for sodium nitrite; sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1856135	CA 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Sodium Nitrite and Sodium Thiosulfate

Last updated: August 4, 2025

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Introduction

The global pharmaceutical landscape is marked by the evolution of specialized compounds like sodium nitrite and sodium thiosulfate, which are integral to medical treatments and emerging therapeutic applications. Both compounds, traditionally used in specific clinical contexts, are experiencing renewed interest driven by advances in medical research, regulatory developments, and market demand shifts. This analysis provides a comprehensive overview of the market dynamics and financial trajectory for these drugs, emphasizing manufacturing, regulatory factors, competitive landscape, and future growth prospects.

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Overview of Sodium Nitrite and Sodium Thiosulfate

Sodium Nitrite
A colorless to yellowish crystalline powder, sodium nitrite (NaNO₂) has long served as a medication for cyanide poisoning, a food additive, and a preservative in cured meats. In clinical settings, it acts primarily as an antidote to cyanide toxicity by converting hemoglobin to methemoglobin, which binds cyanide ions, facilitating detoxification.

Sodium Thiosulfate
Sodium thiosulfate (Na₂S₂O₃) functions primarily as an antidote to cyanide poisoning and in the treatment of calciphylaxis, a severe, calcific vascular disease, especially among dialysis patients. Its antioxidant properties and ability to neutralize halogenated compounds also encourage broader research into its therapeutic potential.

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Market Drivers

1. Increasing Incidence of Poisoning Cases

The prevalence of cyanide poisoning—often resulting from industrial accidents, fire-related inhalation exposures, and attempted suicides—continues to propel demand for established antidotes like sodium nitrite and sodium thiosulfate. According to the World Health Organization (WHO), occupational exposure and accidental poisonings remain significant, supporting a steady requirement for emergency therapies.

2. Growing Use in Medical Emergencies and Critical Care

Hospital protocols increasingly recognize these compounds as vital in emergency responses, especially in regions with high industrial activity. The 2010 revisions to antidote management guidelines by the U.S. CDC, emphasizing sodium nitrite and sodium thiosulfate in cyanide antidote administration, reinforce their importance in medical kits worldwide.

3. Expanding Therapeutic Research and Novel Applications

Recent clinical research explores sodium thiosulfate's antioxidant and cytoprotective properties beyond antidotal use, including potential in cancer therapy and protective agents against radiotherapy-induced damage. These studies support future market expansion as new indications are validated.

4. Regulatory and Patent Activity

Intellectual property rights and regulatory approvals influence market exclusivity. While sodium nitrite and sodium thiosulfate are generic compounds, recent patents covering novel formulations, delivery systems, and combination therapies suggest strategic monetization opportunities that can shape market dynamics.

5. Increased Production and Supply Chain Optimization

Manufacturers are focusing on scalable synthesis processes, quality assurance, and regulatory compliance to meet rising global demand. Market players invest in capacity expansion, particularly in emerging markets such as Asia-Pacific, where healthcare infrastructure improvements boost access.

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Market Challenges

1. Limited Patent Protection and Price Competition

Both drugs are off-patent, resulting in commoditized markets with aggressive price competition. This compresses profit margins and discourages investments in innovative formulations without exclusivity or proprietary advantages.

2. Regulatory Hurdles

Despite established clinical use, evolving regulatory standards impose rigorous manufacturing and safety protocols, especially concerning residual impurities and stability. Differences across jurisdictions may delay product approvals and market entry.

3. Supply Chain Disruptions

Global supply chain vulnerabilities, particularly for precursor chemicals, can impact manufacturing continuity. Political instability, environmental regulations, and transportation issues influence product availability and pricing stability.

4. Limited Market Diversification

Currently, these drugs are primarily used as antidotes, limiting near-term growth unless new indications emerge. Expanding into broader therapeutic applications remains challenging due to regulatory and scientific validation requirements.

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Financial Trajectory and Market Outlook

1. Market Size and Growth Forecast

The global antidote market, encompassing sodium nitrite and sodium thiosulfate, was valued at approximately USD 250–300 million in 2022. Predominantly driven by emergency medical applications, the market exhibits a compound annual growth rate (CAGR) of around 4–6% through 2028, considering both developed and emerging economies.

Emerging markets, particularly in Asia-Pacific and Latin America, are projected to experience higher growth rates (up to 7–8%), driven by increased healthcare infrastructure investments, regulatory harmonization, and rising industrialization.

2. Segment-Specific Financial Trends

• Sodium Nitrite: Its role as a critical antidote ensures relatively stable demand. However, the price sensitivity in generic manufacturing constrains margins. Opportunities arise from developing combination kits and novel delivery mechanisms that command premium pricing.

• Sodium Thiosulfate: The expanding use in treating calciphylaxis and potential off-label applications support growth. R&D investments into new therapeutic indications could diversify revenue streams, albeit requiring significant regulatory approval timelines.

3. Impact of Emerging Therapies and Patent Expiry

While existing drugs are off-patent, strategic companies may develop proprietary formulations or controlled-release systems, creating niche markets with higher margins. Conversely, generic competition and commoditization are likely to exert downward pressure on prices.

4. Investment and M&A Activity

The market has seen sporadic mergers and acquisitions, mainly driven by larger pharmaceutical firms aiming to secure antidote supplies or diversify their critical care portfolios. Private equity interest remains moderate but could rise if new applications for these compounds materialize.

5. Regulatory and Policy Influence

Stringent regulatory oversight, particularly from the FDA and EMA, influences the financial trajectory by requiring ongoing safety and efficacy data, impacting R&D costs and commercialization timelines. Conversely, supportive policies—such as stockpiling strategies for disaster preparedness—can bolster demand stability.

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Strategic Opportunities

• Development of novel formulations (e.g., inhalable or injectable variants) to enhance clinical utility and maximize market share.
• Exploration of new therapeutic indications, leveraging sodium thiosulfate's antioxidant properties for conditions such as cancer or radioprotection.
• Expansion into pipeline partnerships with biotech firms focusing on cyanide-related or toxin-related therapeutics.
• Engagement with government agencies to secure procurement contracts linked to public health preparedness.

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Conclusion

The market dynamics for sodium nitrite and sodium thiosulfate are characterized by steady, predominantly demand-driven growth shaped by their established roles as critical antidotes. While challenges such as price competition, regulatory hurdles, and limited diversification exist, ongoing research and emerging therapeutic opportunities could influence their financial trajectories positively. Market players must strategically leverage innovation, regulatory navigation, and global supply chain management to capitalize on the steady need for these compounds.

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Key Takeaways

• Stable Demand Driven by Medical Emergencies: Both compounds remain essential in cyanide poisoning management, ensuring consistent global market demand.
• Growth Opportunities in Emerging Markets: Asia-Pacific and Latin America present high-growth potential due to healthcare infrastructure expansion.
• Innovation as a Differentiator: Developing proprietary formulations or new indications can create premium markets despite generic competition.
• Regulatory Compliance Is Critical: Maintaining compliance and safety standards sustains market access and mitigates risks.
• Supply Chain Optimization: Reliable sourcing of precursor chemicals and manufacturing capacity are vital for market stability and growth.

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Frequently Asked Questions

1. What are the primary therapeutic uses of sodium nitrite and sodium thiosulfate?
   Sodium nitrite is primarily used as an antidote for cyanide poisoning, facilitating detoxification by forming methemoglobin. Sodium thiosulfate also treats cyanide poisoning, acting as a sulfur donor to assist in cyanide detoxification, and is used for calciphylaxis in dialysis patients.

2. How does the patent landscape affect the market for these compounds?
   Both sodium nitrite and sodium thiosulfate are off-patent, leading to commoditization, intense price competition, and limited exclusivity. Patent activity generally pertains to formulations, delivery systems, or combination therapies rather than the raw compounds themselves.

3. What are the main market challenges facing these drugs?
   Challenges include price competition in generic markets, regulatory hurdles, supply chain disruptions, and limited diversification beyond their established indications.

4. What emerging applications could influence the market trajectory?
   Ongoing research into sodium thiosulfate's antioxidant effects may lead to new therapeutic uses, expanding beyond antidotal therapy into areas like radioprotection and cancer treatment.

5. How do regulatory standards impact the growth prospects of these drugs?
   Stringent safety and manufacturing standards can lengthen approval timelines and increase costs but are necessary to maintain market access, especially as demand rises globally and new formulations are developed.

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References

1. World Health Organization. (2022). Global Poisoning Statistics.
2. CDC. (2010). Guidelines for Cyanide Antidotes.
3. MarketResearch.com. (2022). Global Antidote Market Analysis.
4. PharmTech. (2021). Developments in Cyanide Antidotes.
5. Clinical Trials Registry. (2022). Emerging Research on Sodium Thiosulfate.