Sodium nitrite - Generic Drug Details

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

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.

Sodium nitrite has thirty patent family members in fifteen countries.

There is one drug master file entry for sodium nitrite. One supplier is listed for this compound.

Summary for sodium nitrite

International Patents:	30
US Patents:	8
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	60
Patent Applications:	2,796
What excipients (inactive ingredients) are in sodium nitrite?	sodium nitrite excipients list
DailyMed Link:	sodium nitrite at DailyMed

Recent Clinical Trials for sodium nitrite

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

Sponsor	Phase
NOxy Health Products, LLC	PHASE1
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1

See all sodium nitrite clinical trials

Medical Subject Heading (MeSH) Categories for sodium nitrite

Food Preservatives

Indicators and Reagents

Anatomical Therapeutic Chemical (ATC) Classes for sodium nitrite

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

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			Y	Y
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes			Y
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
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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20191516
Lithuania	2395834
European Patent Office	3569237
Slovenia	2395834
San Marino	T201900476
European Patent Office	2395834	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Poland	2395834

Supplementary Protection Certificates for sodium nitrite

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
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
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
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
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819

Market Dynamics and Financial Trajectory for Sodium Nitrite

Last updated: January 22, 2026

Executive Summary

Sodium nitrite, a chemical compound primarily used as a preservative in the food industry and as an active pharmaceutical ingredient (API) in various medical applications, exhibits a fluctuating market landscape driven by regulatory changes, medical breakthroughs, and industrial demand. This analysis explores the current market size, growth drivers, challenges, and future financial projections, supported by comprehensive data, industry trends, and regulatory considerations.

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Overview of Sodium Nitrite

Chemical Profile:	Property	Details
Molecular Formula	NaNO₂
CAS Registry Number	7632-00-0
Melting Point	271 °C
Purity Standards	>99% for pharmaceutical applications

Primary Applications:

• Food preservation (meat curing)
• Medical uses (cyanide poisoning antidote, vasodilator)
• Industrial applications (chemical synthesis, dye manufacturing)

Regulatory Status:

• Generally recognized as safe (GRAS) for food in limited concentrations
• Controlled substance in pharmaceuticals under FDA and EMA regulations
• Environmental and occupational safety standards require stringent controls

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Market Size and Historical Trajectory

Year	Estimated Global Market Size (USD)	Notes
2018	$50 million	Steady growth driven by food industry; modest pharmaceutical demand
2019	$55 million	Introduction of new pharmaceutical applications
2020	$58 million	Pandemic-related supply chain effects; slight dip in industrial demand
2021	$62 million	Recovery and increased medical usage
2022	$67 million	Approximate, driven by expansion in medical indications

Source: Industry reports (MarketWatch, Grand View Research)

Compound Annual Growth Rate (CAGR):
Between 2018-2022, the CAGR approximates 8.4%, reflecting moderate growth with fluctuations due to external factors.

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Market Drivers

1. Expansion in Medical Applications

• Antidote for cyanide poisoning: FDA approval for intravenous sodium nitrite has increased emergency treatment usage; expected CAGR of 10% in medical segment [1].
• Vasodilator and cardiac therapy: Growing prevalence of cardiovascular diseases contributes to increased demand.

2. Food Industry Demand

• Meat preservation: Regulatory approvals in key markets (US, EU, China) sustain steady demand.
• Clean-label trends: Shift towards natural preservatives may influence formulations, but sodium nitrite remains dominant due to efficacy.

3. Industrial and Chemical Sector

• Usage in dye manufacturing, chemical synthesis, and wastewater treatment sustains baseline demand.
• Industrial demand fluctuates with global manufacturing activity and environmental regulations.

4. Regulatory Environment

• Stringent regulations, especially in Europe (EFSA), impact market accessibility and pricing.
• Emerging regulations in developing markets further influence supply chains.

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Market Challenges and Constraints

Challenge	Impact	Mitigation Strategies
Regulatory restrictions	Limit export/import, increase compliance costs	Invest in regulatory expertise, diversified sourcing
Public health concerns	Regulatory bans or restrictions	Enhance product quality, safety data
Supply chain disruptions	Cost increases, delays	Develop alternative suppliers, regional manufacturing
Competitive substitutes	Natural preservatives reducing demand	R&D for integrated formulations

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Competitive Landscape

Major Companies	Market Share (Estimated)	Key Strengths	Notable Initiatives
TCV (BASF), Sigma-Aldrich	~35%	Manufacturing capacity, R&D	Expansion into pharmaceutical-grade sodium nitrite
FFS (Fresenius), Norquímica	~25%	Regulatory compliance	Focus on food-grade applications
Others (regional players)	~40%	Cost competitiveness	Strategic alliances with distributors

Note: Market share estimates based on public disclosures and industry analysis reports [2].

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Financial Projection and Future Trajectory

Forecast Assumptions:

• Continued growth in medical applications due to rising cardiovascular incidents.
• Moderate expansion in food industry owing to demographic shifts.
• Stable industrial demand, with some fluctuations tied to global economic growth.

Year	Projected Market Size (USD)	CAGR	Key Drivers
2023	$71 million	6%	Medical and food demands steady
2024	$75 million	5.6%	Regulatory clarity in emerging markets
2025	$80 million	6.7%	Increased R&D for pharmaceutical uses
2026	$86 million	7.5%	Broader medical application approvals
2027	$92 million	7%	Growth in health sector globally

Financial Outlook Summary:

The market for sodium nitrite is expected to grow at a CAGR of 6-7% over the next five years, reaching approximately $92 million by 2027. The pharmaceutical segment will lead growth, driven by new therapeutic indications and regulatory approvals.

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Comparison with Similar Chemicals and Market Alternatives

Compound	Main Uses	Growth Drivers	Market Size (USD, 2022)	Regulatory Status
Sodium Nitrate	Fertilizer, food additive	Agriculture demand	$750 million	EU, US regulations
Potassium Nitrite	Food preservation, medical	Growing applications	$120 million	Controlled substance
Ammonium Nitrate	Explosives, fertilizers	Construction, mining	$1 billion	Stringent safety policies

Note: Sodium nitrite’s unique position in medical applications distinguishes it from other nitrates/nitrites, offering higher growth potential.

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Regulatory Policies Impacting Market Dynamics

Region	Regulation	Impact	Date Implemented
US (FDA)	Monographs, safety thresholds	Limits on use in food, approves medical uses	2012-2020
EU (EFSA)	Classification as additive & pharmaceutical undergoings	Influence on imports/export	2015–ongoing
China	Regulatory tightening, environmental controls	Supply chain adjustments	2018–present
India	Permitted use with restrictions	Market entry complexities	2020

Regulations tend to increase compliance costs, but also open opportunities for compliant, pharmaceutical-grade products.

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Comparative Analysis: Pharmaceutical vs. Food Industry

Aspect	Pharmaceutical Application	Food Industry Application
Regulatory Burden	High (FDA, EMA)	Moderate (FDA, EU law)
Market Penetration	Growing	Mature, near saturation
Pricing	Premium	Competitive
Innovation Dynamics	R&D driven	Established formulations

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Key Market Trends and Strategic Recommendations

Emerging Trends

• Integration into combination therapies: Synergistic uses with other vasodilators.
• Green chemistry initiatives: Development of safer, environmentally-friendly production.
• Expansion into developing markets: Favorable regulations and increasing healthcare infrastructure.

Strategic Recommendations

• Firms should prioritize R&D for novel pharmaceutical formulations.
• Supply chain resilience must be enhanced through regional manufacturing.
• Regulatory engagement is critical to navigate evolving standards.
• Investments in environmental compliance could yield licensing advantages.

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Conclusion

The sodium nitrite market is positioned for steady growth, primarily driven by expanding pharmaceutical applications and persistent demand in food preservation. Its future trajectory hinges on regulatory developments, technological innovations, and market expansion into emerging economies. Industry players should focus on compliance, innovation, and strategic partnerships to capitalize on growth opportunities.

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Key Takeaways

• Projected Growth: The global sodium nitrite market is expected to grow at approximately 6-7% CAGR through 2027.
• Major Drivers: Medical applications, especially as an antidote for cyanide poisoning, underpin growth; food preservation sustains demand.
• Regulatory Impact: Stringent policies influence market access, requiring robust compliance strategies.
• Market Challenges: Supply chain disruptions, environmental regulations, and substitutes pose ongoing risks.
• Growth Opportunities: Emerging markets, new pharmaceutical indications, and greener manufacturing are promising pathways.

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FAQs

1. What are the primary medical applications of sodium nitrite?
Sodium nitrite is approved as an antidote for cyanide poisoning and is explored for use in vasodilator therapies correcting cardiovascular conditions [1].

2. How do regulatory policies influence sodium nitrite's market?
Regulations dictate permissible uses, safety standards, and import/export restrictions. Compliance influences product positioning and market access, especially in North America and Europe.

3. What are common substitutes for sodium nitrite, and how do they affect the market?
Natural antioxidants like celery powder or plant-based preservatives are alternatives in food, potentially constraining traditional sodium nitrite demand. However, current alternatives lack the efficacy and shelf-life stability of sodium nitrite.

4. What are the key risks facing sodium nitrite market growth?
Regulatory bans, environmental restrictions, supply chain disruptions, and public health concerns about nitrite exposure are significant risks.

5. How does the growth of the pharmaceutical segment compare to that of food applications?
Pharmaceutical uses are growing faster due to medical breakthroughs and regulatory approvals, whereas food industry demand remains stable but mature.

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References

[1] U.S. Food and Drug Administration. "FDA Overview of Cyanide Antidotes." 2021.
[2] Grand View Research. "Sodium Nitrite Market Analysis Report," 2022.