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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium nitrite has twenty-eight patent family members in fourteen countries.

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

Summary for sodium nitrite

International Patents:	28
US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	58
Patent Applications:	2,128
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
University of Alabama at Birmingham	Phase 1
University of Alabama at Birmingham	Early Phase 1
National Institutes of Health (NIH)	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	10,479,686		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	9,585,912		Y	Y
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	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
Denmark	3569237
Croatia	P20191516
Portugal	3569237
European Patent Office	3862007	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	2015199764	亜硝酸ナトリウムを含む医薬組成物 (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
European Patent Office	2395834	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Lithuania	3569237

Supplementary Protection Certificates for sodium nitrite

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
0806968	SPC/GB07/011	United Kingdom		PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
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
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201

Sodium Nitrite Market Dynamics and Financial Trajectory

Market Overview

The sodium nitrite market is poised for significant growth, driven by its versatile applications across various industries. Here’s a comprehensive look at the market dynamics and financial trajectory of sodium nitrite.

Global Market Size and Growth

As of 2023, the global sodium nitrite market was valued at approximately USD 428.15 million[1][3][4].

• It is expected to grow at a Compound Annual Growth Rate (CAGR) of around 4.2% to 4.3% from 2024 to 2030, reaching nearly USD 574.89 million to USD 580.8 million by 2030[1][2][4].

Regional Insights

• Asia Pacific: This region dominates the global sodium nitrite market, holding a market share of 59.75% in 2023. Countries like China, Japan, and India are key drivers due to rapid urbanization, rising disposable incomes, and the growth of the meat processing industry[1].
• North America: The United States is a significant consumer of sodium nitrite, driven by demand from the processed meat industry. The market here is expected to grow steadily due to changing consumer lifestyles and increased urbanization[3].

Key Applications

• Meat Curing: The primary driver of the sodium nitrite market is its use in meat curing applications. It is essential for preserving processed meat products like sausages, bacon, and ham by acting as an antioxidant and antibacterial agent[2][3][4].
• Pharmaceuticals: Sodium nitrite is used in cardiovascular therapy to alleviate the consequences of hypotension. The pharmaceutical industry's increasing research and development activities are expected to boost demand for pharmaceutical-grade sodium nitrite[3].
• Food and Beverage: Besides meat, sodium nitrite is used to preserve other perishable foods, maintaining their taste and freshness[3].
• Textiles and Rubber: These industries also rely on sodium nitrite for various applications, contributing to the overall demand[1][2][3].

Market Trends

• Increasing Demand for Processed Meat: The rising demand for processed meat products is a significant trend driving the sodium nitrite market. This is particularly evident in regions with growing populations and changing dietary habits[2][3][4].
• Natural Sources: There is an increasing interest in natural sources of sodium nitrite, such as celery and lettuce, especially in North America and Europe. This trend may influence market dynamics in the future[4].

Price Trends

• Global Pricing: The prices of sodium nitrite are expected to maintain an upward trajectory due to rising raw material costs and ongoing supply chain challenges. For instance, the cost of nitric acid, a crucial raw material, has been increasing[5].
• Regional Variations: In Asia, particularly in China, prices saw a slight uptick in the second quarter of 2024 due to rising raw material costs. In North America, the market experienced a gradual price increase in Q3 2024, influenced by overseas production costs and robust demand from key sectors[5].

Competitive Landscape

• The sodium nitrite market is highly fragmented with a large number of manufacturers. Key players include BASF SE, Deepak Nitrite Ltd., Airedale Chemical Company Ltd., UralChem JSC, and Shijizhuang Fengshan Chemical Co. Ltd.[4].
• These companies have established global supply chains through in-house supply channels or third-party distributors, ensuring a strong market presence[4].

Supply Chain and Distribution

• Multinational corporations have set up extensive distribution networks to supply sodium nitrite globally. For example, BASF SE uses third-party distributors to reach various markets[4].
• The stability in raw material costs, such as sodium hydroxide, helps buffer against significant price fluctuations, but supply chain challenges and raw material costs remain critical factors[5].

Challenges and Opportunities

• Supply Chain Disruptions: Fluctuations in raw material costs and supply chain disruptions can impact the market. For instance, the shortage of key inputs like ammonia has affected production rates[5].
• Regulatory Environment: Changes in regulatory policies, especially regarding food preservatives, can influence market dynamics. However, the essential role of sodium nitrite in preserving food safety is likely to maintain its demand[3].

Industry Expert Insights

"The demand for sodium nitrite is anticipated to be driven by its utilization in meat curing applications. The pharmaceutical industry's involvement in research and development has also increased the use of sodium nitrite over the years."[3]

Key Takeaways

• The global sodium nitrite market is expected to grow significantly, driven by its use in meat curing, pharmaceuticals, and other industries.
• Asia Pacific, particularly China, dominates the market due to rapid urbanization and the growth of the meat processing industry.
• Rising demand for processed meat products and increasing research in pharmaceuticals are key trends.
• Price trends are influenced by raw material costs and supply chain challenges.
• The market is highly competitive with several key players maintaining a strong global presence.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global sodium nitrite market? A: As of 2023, the global sodium nitrite market was valued at approximately USD 428.15 million[1].

Q: What is the expected CAGR of the sodium nitrite market from 2024 to 2030? A: The market is expected to grow at a CAGR of around 4.2% to 4.3% from 2024 to 2030[1][2][4].

Q: Which region dominates the global sodium nitrite market? A: The Asia Pacific region, particularly China, dominates the global sodium nitrite market with a market share of 59.75% in 2023[1].

Q: What are the primary applications of sodium nitrite? A: The primary applications include meat curing, pharmaceuticals, food and beverage preservation, and use in textiles and rubber industries[2][3][4].

Q: How do raw material costs affect the price of sodium nitrite? A: Rising raw material costs, such as those of nitric acid and sodium hydroxide, are expected to maintain an upward trajectory in sodium nitrite prices[5].

Sources:

1. Maximize Market Research - Sodium Nitrite Market: Global Industry Analysis and Forecast 2030
2. Future Market Insights - Sodium Nitrite Market Size, Industry Share & Trends – 2032
3. SkyQuest Technology - Sodium Nitrite Market Size, Share, Trends Forecast, 2031
4. Grand View Research - Sodium Nitrite Market Size, Share, Trends Forecast, 2030
5. Procurement Resource - Sodium Nitrite Price Trend, Index, News, Chart, Database

Last updated: 2024-12-17