sodium nitrite - Profile

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

Sodium nitrite is the generic ingredient in two branded drugs marketed by Hope Pharms and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Summary for sodium nitrite

International Patents:	30
US Patents:	8
Tradenames:	2
Applicants:	1
NDAs:	2

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

Constraining patent/regulatory exclusivity:

9,687,506

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.

US Patents and Regulatory Information for sodium nitrite

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes	9,687,506		Y
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes	8,568,793		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	11,753,301		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,345,724		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,687,506		Y

International Patents for sodium nitrite

Country	Patent Number	Title	Estimated Expiration
Australia	2010213743	Sodium nitrite-containing pharmaceutical compositions
Canada	2752129	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Cyprus	1121939
Cyprus	1124426
Denmark	2395834
Denmark	3569237

Supplementary Protection Certificates for sodium nitrite

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	1890039-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2822954	SPC/GB18/031	United Kingdom		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123

Investment Scenario and Fundamentals Analysis for Sodium Nitrite

Last updated: February 20, 2026

What is the Market for Sodium Nitrite?

Sodium nitrite (NaNO₂) is a chemical used primarily as a food additive, preservative in cured meats, and in pharmaceutical applications. It is also an intermediary in chemical synthesis and a corrosion inhibitor in industrial processes. The global demand for sodium nitrite is driven by its roles in food preservation, industrial applications, and emerging pharmaceutical uses.

The global sodium nitrite market was valued at approximately USD 245 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of roughly 4.2% through 2027, reaching USD 300 million. Growth drivers include increasing demand for processed foods, expansion of industrial applications, and regulatory approvals for new pharmaceutical indications.

What Are the Key Market Drivers and Barriers?

Drivers:

• Food industry expansion: Sodium nitrite's role in meat curing is critical, especially in developing regions experiencing rapid urbanization.
• Industrial uses: Corrosion prevention and chemical synthesis industries rely on sodium nitrite.
• Pharmaceutical development: Emerging use cases in targeted therapies, emergency medicine, and gasotransmitter research bolster future potential.

Barriers:

• Regulatory restrictions: Stringent regulations on nitrogen compounds in food and medicine limit usage scope and scale.
• Environmental concerns: Waste management and potential environmental impact pose risks, incurring costs or restrictions.
• Market volatility: Price fluctuations driven by raw material costs (e.g., sodium compounds, nitric acid) impact profitability.

What Are the Core Fundamentals of Sodium Nitrite Production?

Raw Material Supply:

• Sodium hydroxide, sodium nitrate, and nitric acid are primary inputs.
• Raw material prices are sensitive to feedstock availability, energy costs, and geopolitical stability.

Manufacturing Processes:

• Chemical oxidation: Sodium nitrate is reduced using sulfur dioxide or other reducing agents.
• Electrochemical methods: Used primarily in high-purity applications, offering lower impurities.
• Key players: Major chemical manufacturers include FMC Corporation, Fermion, and American Elements.

Cost Structure:

• Raw materials account for approximately 60-70% of production costs.
• Energy consumption and labor costs constitute the remaining share.
• Typical production cost ranges from USD 0.70 to USD 1.10 per kilogram, depending on scale and process efficiency.

Regulatory & Quality Standards:

• Food-grade sodium nitrite must meet standards set by FDA (U.S.), EFSA (Europe), and other authorities.
• Pharmaceutical-grade products require compliance with cGMP (current Good Manufacturing Practice), adding complexity and costs.

What Are the Pharmacological and Emerging Applications?

Food Preservation:

• Approved for use in processed meats for inhibiting bacterial growth.
• Regulatory limits: Up to 200 ppm in the U.S. and EU.

Pharmaceutical Uses:

• Investigational therapies: Role in NO (nitric oxide) donor systems for cardiovascular diseases.
• Emergency medicine: Use in cyanide poisoning antidotes.
• Research compounds: Explored as a precursor in gasotransmitter delivery systems.

Patent and Commercialization Outlook:

• Limited current pharmaceutical patents specific to sodium nitrite.
• Potential for new formulations or delivery mechanisms to extend lifecycle.

Who Are Key Industry Players?

Company	Market Share	Core Focus	Notable Attributes
FMC Corporation	High	Chemical manufacturing	Extensive global footprint, diversified product lines
Fermion	Moderate	Specialty chemicals, pharmaceuticals	Focus on pharmaceutical-grade products
American Elements	Niche	Custom chemicals, nanomaterials	Rapid custom synthesis, niche markets

What Are Investment Risks?

• Regulatory tightening could restrict applications.
• Raw material price volatility impacts margins.
• Environmental liabilities increase with stricter regulations.
• Market saturation in food applications limits growth potential.

How Does Sodium Nitrite Compare to Alternatives?

Alternative	Application	Advantages	Disadvantages
Sodium erythorbate	Food preservation	Reduces nitrite amount needed	Less effective as a curing agent
Nitrate compounds	Food curing	Longer shelf life	Regulatory restrictions more stringent
Organic acids (e.g., lactic acid)	Food preservation	Natural appeal	Limited efficacy in meat curing

Strategic Investment Considerations

• Focus on specialty or pharmaceutical-grade supply chains.
• Monitor regulatory developments, especially in food safety.
• Consider vertical integration to control raw material costs.
• Invest in R&D for novel applications in NO therapeutics or delivery mechanisms.

Key Takeaways

• Market growth driven by food, industrial, and pharmaceutical sectors.
• Production relies heavily on raw material costs and environmental compliance.
• Regulatory landscape is a key risk factor with potential to restrict use.
• Pharmaceutical applications present high-margin, innovation-driven opportunities.
• Major players include FMC, Fermion, and American Elements, with niche opportunities for biotech collaborations.

FAQs

1. What are the main growth drivers for sodium nitrite?
The increase in processed meat consumption and industrial applications drive growth. Emerging pharmaceutical uses also contribute.

2. How sensitive is the market to raw material prices?
Very sensitive. Raw materials account for a significant portion of costs, with fluctuations impacting profitability.

3. What regulatory hurdles could affect sodium nitrite?
Food safety limits, environmental regulations, and pharmaceutical manufacturing standards pose potential restrictions.

4. Are there significant patent barriers in this market?
Generally low for bulk sodium nitrite, but proprietary formulations or delivery systems could provide patent opportunities.

5. What are the main risks associated with investing in sodium nitrite?
Regulatory restrictions, raw material price volatility, environmental liabilities, and market saturation in food applications.

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References

[1] MarketWatch. (2023). Sodium Nitrite Market Forecasts. Retrieved from https://www.marketwatch.com/

[2] U.S. Food and Drug Administration (FDA). (2022). Food Additive Status List.

[3] European Food Safety Authority (EFSA). (2022). Chemical safety assessments.

[4] Grand View Research. (2022). Global Sodium Nitrite Market Size & Trends.

[5] Ritchie, J., & Wilson, L. (2020). Industrial Chemical Manufacturing Dynamics. Journal of Chemical Industry, 45(3), 150-165.