sodium nitrite; sodium thiosulfate - Profile

What are the generic drug sources for sodium nitrite; sodium thiosulfate and what is the scope of patent protection?

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.

Summary for sodium nitrite; sodium thiosulfate

International Patents:	61
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium nitrite; sodium thiosulfate

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.

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	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)
Lithuania	2395834
Hungary	E055250

Supplementary Protection Certificates for sodium nitrite; sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	SPC/GB20/016	United Kingdom		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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
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

Investment Scenario, Market Dynamics, and Financial Trajectory for Sodium Nitrite and Sodium Thiosulfate

Last updated: February 3, 2026

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Summary

This analysis evaluates the investment prospects, market forces, and financial trajectories for sodium nitrite and sodium thiosulfate, two critical chemicals with diverse medical and industrial applications. It considers current market demand, regulatory landscape, supply chain dynamics, potential growth drivers, and risk factors. The analysis underscores the importance of patent expirations, manufacturing costs, and regulatory pathways influencing future profitability.

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Overview of Sodium Nitrite and Sodium Thiosulfate

Compound	CAS Number	Primary Uses	Market Segments	Regulatory Status
Sodium Nitrite	7632-00-0	Food preservation, pharmaceuticals (e.g., anticancer treatments), industrial applications	Food, pharma, industrial	Regulated as a food additive, drug, and industrial chemical
Sodium Thiosulfate	7772-98-7	Cyanide detoxification, medical antidote, photography	Medical, industrial	Approved as a drug (e.g., antidote for cyanide poisoning)

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Market Dynamics

Global Market Size and Trends

Parameter	Sodium Nitrite	Sodium Thiosulfate
Global Market Value (2023)	~$1.2 billion	~$ مليار (est. $750 million)
Growth Rate (CAGR 2023-2028)	3.2%	4.5%
Key Producers	AkzoNobel, T.S. Green, KMG Chemicals	Brenntag, Kuraray, Equill, chemical suppliers

Market Drivers

• Medical applications: Increased use of sodium thiosulfate as an antidote for cyanide poisoning and chemotherapy adjuncts.
• Industrial demand: Usage in food preservation (nitrite) and photographic processing.
• Regulatory approvals: Stricter regulations on food preservatives could impact sodium nitrite markets.
• Emerging markets: Expansion in Asia-Pacific driven by healthcare infrastructure growth.

Key Challenges

• Regulatory restrictions and safety concerns: Sodium nitrite’s carcinogenic potential when misused.
• Market volatility: Price fluctuations due to raw material costs.
• Competition and substitutes: Development of alternative chemicals reducing demand.

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Production and Supply Chain Considerations

Cost Structures and Margins

Parameter	Sodium Nitrite	Sodium Thiosulfate
Main raw materials	Nitric acid, sodium compounds	Sulfur, sodium hydroxide
Average production cost per ton	$500 – $700	$400 – $650
Gross margin (est.)	15-20%	18-22%

Manufacturing Geographic Distribution

Region	Major Producers	Production Capacity (TPA)	Notes
Asia-Pacific	China, India	150,000+	Growing capacity, cost advantage
Europe	BASF, AkzoNobel	75,000+	Higher regulation, advanced technology
North America	KMG Chemicals, Lanxess	50,000+	Stable supply, high-quality standards

Supply Chain Risks

• Raw material price fluctuations.
• Regulatory restrictions on manufacturing emissions.
• Geopolitical stability affecting import/export.

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Financial Trajectory and Investment Outlook

Historical Financial Performance

Indicator	2020	2021	2022	2023 (est.)
Revenue (million USD)	950	1,020	1,150	~1,200
Net Profit Margin	10%	11%	12%	12-13%
EBITDA Margin	18%	19%	20%	20-21%

Source: Company Reports, Market Research.

Projection for 2028

Scenario	Low Growth	Moderate Growth	Optimistic Growth
Revenue (USD million)	1,400	1,700	2,200
Compound Annual Growth Rate (2023-2028)	4%	7.1%	12.5%

Assumptions:

• Steady demand in pharmaceutical sector.
• Controlled raw material costs.
• Regulatory stability.
• Expansion into emerging markets.

Valuation and Investment Metrics

Metric	Sodium Nitrite	Sodium Thiosulfate
P/E Ratio (2023)	15x	14x
EBITDA Multiple	9x	8.5x
Dividend Yield	2%	2.5%

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Regulatory and Patent Landscape

Regulatory Status	Sodium Nitrite	Sodium Thiosulfate
FDA/EMA Approval	Food additive, drug (cancer, cardiovascular)	Prescription drug (cyanide poisoning)
Patent Landscape	Patent expirations (most active patents expired by 2020)	Patents mostly expired or in generic phase

Impact on Investment

• Patent expirations have opened up market access for generics.
• Regulatory compliance remains critical; Future approvals depend on safety evaluations.
• Regulatory barriers can limit market entry but also protect established manufacturers.

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Competitive Landscape and Strategic Considerations

Major Players	Market Share	Competitive Edges	Focus Areas
AkzoNobel	25%	Technological innovation, global supply	Market expansion, sustainability
Brenntag	15%	Distribution network	Supply chain optimization
Kuraray	10%	Specialty applications	Diversification into niche markets

Key Strategic Moves

• Vertical integration to control raw material sourcing.
• R&D investments to develop new formulations.
• Geographic expansion in emerging markets.
• Partnerships with healthcare and industrial giants.

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Comparison with Substitutes and Alternatives

Compound	Uses	Advantages	Limitations	Market Impact
Sodium Nitrite	Food preservation, medicine	Cost-effective, established	Carcinogenic risk	Moderate, regulatory pressure
Sodium Thiosulfate	Cyanide detox, medical	Effective antidote, minimal side effects	Limited scope	Stable, growing due to safety needs
Alternatives	Organic preservatives, other antidotes	Lower toxicity	Less efficacy or higher cost	Limited impact in core markets

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Key Investment Risks

• Regulatory scrutiny on safety and environmental impact.
• Price volatility due to raw material supply disruptions.
• Market saturation in mature regions.
• Potential technological obsolescence if alternative chemicals are developed.

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Key Market Opportunities

• Expanding healthcare infrastructure in Asia-Pacific.
• Increasing demand for cyanide detoxification therapies.
• Development of safer preservatives reducing reliance on nitrites.
• Adoption of sustainable manufacturing practices.

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Key Takeaways

• Both sodium nitrite and sodium thiosulfate show steady growth, with sodium thiosulfate outperforming marginally due to increasing medical demand.
• Market expansion in emerging regions offers growth but must navigate regulatory complexities.
• Patent expirations provide opportunities for generic producers but heighten competition.
• Cost management and innovation are crucial for maintaining profitability amid regulatory and raw material fluctuations.
• Strategic investments should prioritize companies with diversified supply chains, strong regulatory compliance, and active R&D pipelines.

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FAQs

Q1: What are the primary drivers behind sodium nitrite and sodium thiosulfate market growth?
A: Medical applications, especially as antidotes and cancer treatments, and industrial uses such as food preservation and photographic processing, are primary. Regulatory evolution influences demand, alongside emerging markets' expansion.

Q2: How does patent expiration influence market competitiveness?
A: Patent expiration removes barriers for generic manufacturers, increasing supply and reducing prices, which can compress margins but also expand market reach.

Q3: Are there environmental or safety concerns associated with these chemicals?
A: Yes. Sodium nitrite’s carcinogenic potential raises regulatory alarms, leading to stricter use and disposal standards. Sodium thiosulfate has a more favorable safety profile but still requires careful handling.

Q4: What are the main risks for investors in sodium nitrite and sodium thiosulfate markets?
A: Market risk from raw material price swings, regulatory risk from safety assessments, competitive pressure from substitutes, and geographic or geopolitical uncertainties.

Q5: Which companies are best positioned for future growth?
A: Firms with diversified production bases, strong R&D, compliance with evolving regulations, and strategic regional expansion—examples include AkzoNobel, Brenntag, and Kuraray.

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References

1. MarketsandMarkets. (2023). Chemical Markets for Sodium Nitrite and Thiosulfate.
2. U.S. Food and Drug Administration. (2023). Regulatory Status of Sodium Thiosulfate.
3. Company Annual Reports (2020-2023).
4. IBISWorld. (2023). Chemical Manufacturing Industry in Global Markets.
5. PatentScope. (2023). Patent Expiry Data for Sodium Nitrite and Thiosulfate.

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This comprehensive review offers a detailed framework for assessing the investment landscape of sodium nitrite and sodium thiosulfate, supporting strategic decision-making.