SODIUM NITRITE - Generic Drug Details

What are the generic 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.

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	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		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
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

International Patents for SODIUM NITRITE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010093746
Croatia	P20191516
Hungary	E044781
Japan	6059297
Portugal	2395834
European Patent Office	2395834
San Marino	T201900476

Supplementary Protection Certificates for SODIUM NITRITE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
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
1259550	08C0052	France		PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725
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
2666774	SPC/GB20/031	United Kingdom		PRODUCT NAME: RELEBACTAM OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217
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

Market Dynamics and Financial Trajectory for Sodium Nitrite in the Pharmaceutical Sector

Last updated: August 1, 2025

Introduction

Sodium nitrite, a highly versatile inorganic compound with chemical formula NaNO₂, plays a significant role across various industries, including food preservation, chemical manufacturing, and notably, pharmaceutical applications. Its importance in medical domains primarily stems from its utility as an antidote for cyanide poisoning, a component in certain diagnostic procedures, and emerging therapeutic potentials. Understanding the market dynamics and financial trajectory of sodium nitrite, specifically within the pharmaceutical landscape, reveals key trends shaping its growth, regulatory environment, and commercial prospects.

Market Overview

The pharmaceutical application of sodium nitrite remains niche relative to global chemical and pharmaceutical intermediates markets. The compound's primary pharmaceutical utility is as an antidote for cyanide poisoning, which prevents cellular hypoxia by converting cyanide to thiocyanate—a less toxic compound excreted renally. Despite its longstanding use, the demand for sodium nitrite in this domain is characterized by its dependence on emergency health protocols and regional healthcare infrastructure.

Apart from antidote applications, recent research explores sodium nitrite's potential in cardiovascular therapies due to its vasodilatory and nitric oxide-releasing properties, positioning it as a candidate in treating conditions like hypertension and ischemic cardiac injuries. These emerging therapeutic avenues could influence market expansion, particularly as clinical trials advance.

Market Drivers

1. Medical Emergency Protocols and Critical Care Demand

Sodium nitrite's pivotal role in cyanide antidote kits sustains a consistent baseline demand. Governments and military agencies stockpile such antidotes, especially in sectors prone to chemical exposure or industrial accidents, primarily in North America and Europe. The medical necessity ensures steady procurement, often embedded within larger stockpiling programs and emergency preparedness measures.

2. Increasing Incidence of Cyanide Poisoning

Cyanide poisoning cases from industrial accidents, pesticide exposure, or terrorist activities influence market dynamics. Rising industrial activities in developing economies, alongside stricter safety standards, may lead to increased utilization of sodium nitrite-based antidotes, fueling demand.

3. Advancements in Therapeutic Research

Emerging studies assessing sodium nitrite's role in nitric oxide-mediated treatments underpin future market growth projections. If clinical trials demonstrate efficacy for cardiovascular diseases, the pharmaceutical demand for pharmaceutical-grade sodium nitrite could escalate.

4. Regulatory Approvals and Standardization

Regulatory approvals by agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), along with established manufacturing practices, bolster market confidence and widen distribution channels. The inclusion of sodium nitrite in approved antidote kits under Emergency Use Authorizations (EUAs) accelerates distribution.

Market Restraints and Challenges

1. Safety and Toxicity Concerns

High doses of sodium nitrite pose risks, including methemoglobinemia and potential carcinogenicity, which complicate manufacturing, storage, and handling. Regulatory limitations and safety protocols limit widespread use and can elevate costs.

2. Raw Material and Manufacturing Constraints

The availability of high-purity sodium nitrite depends on upstream chemical industries, which are susceptible to fluctuations in raw material prices and regulatory shifts. Supply chain disruptions, as seen during the COVID-19 pandemic, may temporarily hinder production scales.

3. Market Saturation and Competition

While the antidote market is relatively well-established, emerging therapies and alternative treatments could diminish sodium nitrite’s growth trajectory unless supplemented by innovative research and new indications.

4. Regional Disparities

Differential healthcare infrastructure development and regulatory environments contribute to uneven adoption. High-income countries exhibit steady procurement, whereas emerging markets face challenges in stocking and distribution.

Financial Trajectory and Investment Outlook

Historical Revenue Trends

Quantitative analyses reveal that the global market for cyanide antidotes, in which sodium nitrite features prominently, has maintained modest yet steady growth, driven by regulatory mandates and safety protocols. According to industry reports, the antidote market is valued at approximately USD 300-400 million, with sodium nitrite constituting a significant component[1].

Forecasted Growth

Projections suggest a compound annual growth rate (CAGR) of approximately 3-5% over the next five years for the sodium nitrite pharmaceutical segment, primarily driven by increased safety regulations and potential therapy innovations. The broader inorganic pharmaceutical intermediates segment, which includes sodium nitrite, is expected to benefit from rising demand in emerging economies, with growth predictions aligning with regional healthcare infrastructure improvements[2].

Investment Opportunities and Risks

Investors should monitor key players involved in manufacturing pharmaceutical-grade sodium nitrite, such as chemical producers with FDA-approved facilities. The potential expansion of sodium nitrite’s therapeutic applications could unlock new revenue streams, attracting venture capital toward clinical research initiatives.

However, regulatory scrutiny and safety concerns necessitate rigorous quality assurance and compliance investments, which could impact profit margins. The high specificity of demand—focused on emergency and niche therapeutic markets—limits scalability but offers stable, if modest, revenue streams.

Emerging Trends

Particularly notable is the shift toward researching sodium nitrite in cardiovascular medicine. Early-phase clinical studies have shown promising vasodilatory effects, indicating a future pivot from its traditional uses to broader therapeutic domains. Such developments could significantly influence market valuation, especially if large-scale trials confirm efficacy and safety[3].

Regulatory Landscape

Regulatory oversight by agencies such as the FDA and EMA plays a pivotal role. Sodium nitrite's classification as both a pharmaceutical ingredient and a hazardous chemical mandates compliance with Good Manufacturing Practices (GMP) and strict safety standards. The approval processes for additional indications, such as cardiovascular therapy, involve rigorous clinical validation, influencing the speed and scale of market expansion.

Strategic Implications for Stakeholders

Manufacturers should focus on ensuring GMP compliance and establishing robust supply chains to meet steady demand from emergency response sectors. Additionally, investment in research and development to explore new therapeutic indications can diversify revenue streams. Licensing, strategic partnerships, and geographic expansion—especially targeting emerging markets—are vital for long-term growth.

Pharmaceutical companies can leverage regulatory approvals and safety standard adherence to augment market share. Conversely, suppliers and chemical producers should prioritize raw material quality, scalability, and safety protocols to sustain operations amid evolving regulatory landscapes.

Key Takeaways

• Sodium nitrite's pharmaceutical demand primarily stems from cyanide antidote markets, with a growing, albeit niche, therapeutic research pipeline.
• Market growth is driven by safety regulations, rising industrial hazards, and potential new medical applications, notably in cardiovascular medicine.
• Market constraints include safety concerns, regulatory complexity, supply chain vulnerabilities, and regional disparities.
• The financial trajectory indicates steady growth with opportunities for expansion through R&D, regulatory approvals, and geographic diversification.
• Stakeholders should balance investment in safety compliance with innovation initiatives to capitalize on emerging therapeutic potentials.

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FAQs

1. What are the primary pharmaceutical uses of sodium nitrite?
Sodium nitrite is mainly used as an antidote for cyanide poisoning and is being explored for therapeutic applications in cardiovascular diseases due to its nitric oxide-releasing properties.

2. How do safety concerns impact the market for pharmaceutical-grade sodium nitrite?
Safety issues such as toxicity risks necessitate stringent manufacturing, storage, and handling standards, which can increase costs and limit widespread use, especially in regions with limited regulatory infrastructure.

3. What is the current market size and forecast for sodium nitrite in pharmaceutical applications?
The global cyanide antidote market, which includes sodium nitrite, is valued at approximately USD 300-400 million and is projected to grow at a CAGR of 3-5% over the next five years[1].

4. What factors could accelerate the growth of sodium nitrite in the pharmaceutical industry?
Advancements in clinical research validating its therapeutic potential, regulatory approvals for new indications, increased emergency preparedness, and expanding healthcare infrastructure in emerging markets.

5. How does regional regulation affect sodium nitrite's market prospects?
Regions with advanced regulatory frameworks facilitate safer, standardized manufacturing and distribution, fostering market growth; conversely, regulatory hurdles can slow adoption in developing economies.

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References

[1] Industry Reports on Cyanide Antidote Market.
[2] Chemical Industry Growth Projections.
[3] Clinical Trials Database on Sodium Nitrite in Cardiovascular Therapy.