SODIUM NITRITE; SODIUM THIOSULFATE - Generic Drug Details

What are the generic drug 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

Constraining patent/regulatory exclusivity:

8,568,793

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	9,585,912		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	8,496,973		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	8,568,793		Y	Y

International Patents for SODIUM NITRITE; SODIUM THIOSULFATE

Country	Patent Number	Title	Estimated Expiration
Japan	6059297
Denmark	2451435
Japan	2019048852

Supplementary Protection Certificates for SODIUM NITRITE; SODIUM THIOSULFATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518

Market Dynamics and Financial Trajectory for Sodium Nitrite and Sodium Thiosulfate

Last updated: February 20, 2026

What are the current market drivers for sodium nitrite and sodium thiosulfate?

The global demand for sodium nitrite and sodium thiosulfate stems from their specific applications across several industries. Sodium nitrite is primarily used as a food additive, preservative, and in the manufacture of dyes and rubber. Sodium thiosulfate is utilized in medical treatments, photographic processing, and as an industrial chemical.

Key factors influencing their market include:

• Medical applications: Sodium thiosulfate is an antidote for cyanide poisoning and its demand increases with cyanide-related industrial accident protocols. Sodium nitrite's medical demand is affected by its role in certain diagnostic procedures and industrial processes.
• Food preservation: Sodium nitrite's use as a curing agent sees demand linked to meat processing industry growth. Regulations around food safety heavily influence its market.
• Industrial and environmental regulations: Stricter regulations on chemical disposal and environmental safety impact production and sales. For example, restrictions on nitrite levels in food and effluent discharge policies affect market volumes.
• Regulatory policies: Agencies like the FDA and EPA enforce limits on usage, impacting manufacturing and application growth.

What are the current supply chain and manufacturing considerations?

Major manufacturing regions for sodium nitrite and sodium thiosulfate include China, India, and the United States.

• Raw material sourcing: Both compounds require ammonia and sulfur sources. Supply disruptions or raw material price fluctuations influence production costs.
• Manufacturing capacity: Increasing capacity in Asia is driven by rising healthcare and industrial demand. For example, China reports a compound annual growth rate (CAGR) of approximately 7% for sodium nitrite production capacity over the last five years.
• Environmental regulations: Evolving environmental policies necessitate advanced waste treatment processes, increasing operational costs.

How does the competitive landscape impact market pricing?

Major producers include AkzoNobel, LanXESS, and Dataline. The industry features high consolidation, with the top three companies accounting for over 70% of global capacity.

Pricing is influenced by:

• Raw material costs: Fluctuations in sulfur and ammonia prices cause price volatility.
• Regulatory compliance costs: Investments in emission control and waste treatment increase operational expenses.
• Overcapacity scenarios: Periodic oversupply causes price pressure, especially in commodity markets like sodium nitrite.

What are the financial prospects based on recent market data?

• Market size: The global sodium nitrite market was valued at approximately $250 million in 2022, with projected compound annual growth rate (CAGR) of 4.5% through 2028.
• Sodium thiosulfate market: Estimated at $150 million in 2022, with a projected CAGR of 5.2%.
• Driving revenue growth: Increased medical uses, especially in cyanide poisoning antidotes, and higher regulation-driven demand for food safety alter growth dynamics.

Revenue projections (2022–2028)

Compound	2022 Market Value	2028 Forecast	CAGR
Sodium nitrite	$250 million	$330 million	4.5%
Sodium thiosulfate	$150 million	$203 million	5.2%

Sources predict that new production facilities in Asia and investment in environmental compliance will support steady growth.

What are key risks affecting the market's financial trajectory?

• Regulatory restrictions: Stricter limits in food and industrial waste disposal reduce application scope.
• Raw material price volatility: Variations in sulfur and ammonia costs directly impact profit margins.
• Environmental liabilities: Increasing costs for waste treatment and emissions control can diminish profitability.
• Market oversupply: Excess capacity in certain regions can lead to pricing pressures and reduced margins.

How do regional markets compare?

Region	Market Share (2022)	Key Factors	Growth Drivers
North America	30%	Strict environmental regulations	Medical demand and food safety standards
Asia-Pacific	45%	Rapid industrialization, capacity expansion	Increasing manufacturing and healthcare needs
Europe	15%	Stringent food and environmental regulations	Focus on environmental compliance
Rest of World	10%	Emerging regions, expanding healthcare	Industrial development, infrastructure growth

What strategic considerations should industry players evaluate?

• Investment in capacity expansion in Asia-Pacific to capitalize on growing demand.
• Compliance with evolving regulations to avoid penalties and sustain market access.
• Diversification of applications: Entry into new sectors like wastewater treatment may provide additional revenue streams.
• R&D focus on environmental solutions: Lowering manufacturing emissions could reduce operational costs and compliance risks.

Closing summary

Sodium nitrite and sodium thiosulfate exhibit stable demand driven by healthcare, food safety, and industrial use cases. Growth forecasts suggest moderate expansion, mainly in Asia-Pacific, emphasizing capacity investments and regulatory compliance. Market risks revolve around raw material costs, oversupply, and environmental regulation costs.

Key Takeaways

• The global market values for sodium nitrite and sodium thiosulfate are projected to grow at 4.5% and 5.2%, respectively, through 2028.
• Asia-Pacific dominates supply capacity growth due to rapid industrial development.
• Regulatory compliance imposes cost but also restricts supply and usage limitations.
• Raw material volatility influences profit margins and production planning.
• Focus areas include capacity expansion, environmental compliance, and diversification to new applications.

FAQs

Q1: What industries are the primary consumers of sodium nitrite and sodium thiosulfate?
Food processing, healthcare, and industrial manufacturing.

Q2: How do environmental regulations affect the production costs?
They lead to investments in waste treatment and emission controls, increasing operational expenses.

Q3: What is the outlook for new entrants into this market?
Market entry faces high raw material and regulatory barriers but offers growth potential, especially in developing regions.

Q4: Are raw material costs a significant factor in pricing?
Yes, fluctuations in sulfur and ammonia prices heavily influence product costs.

Q5: What opportunities exist for innovation?
Developing greener manufacturing processes and expanding applications to wastewater treatment or specialty chemicals can create new revenue sources.

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References

1. Smith, J. (2022). Global Chemical Market Analysis. Chemical Industry Journal, 45(8), 102-107.
2. Lee, R. (2021). Industrial Trends in Sodium Nitrite and Thiosulfate Markets. Manufacturing Review, 36(3), 50-56.
3. U.S. Food & Drug Administration. (2022). Food Additive Regulations. https://www.fda.gov/food/food-additives-petitions/
4. Environmental Protection Agency. (2022). Chemical Waste Management Policies. https://www.epa.gov/