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Last Updated: December 22, 2024

SODIUM NITRITE Drug Patent Profile


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Which patents cover Sodium Nitrite, and when can generic versions of Sodium Nitrite launch?

Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-eight patent family members in fourteen countries.

The generic ingredient in SODIUM NITRITE is sodium nitrite. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Nitrite

A generic version of SODIUM NITRITE was approved as sodium nitrite by HOPE PHARMS on February 14th, 2012.

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Summary for SODIUM NITRITE
International Patents:28
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 123
Clinical Trials: 58
Patent Applications: 1,397
What excipients (inactive ingredients) are in SODIUM NITRITE?SODIUM NITRITE excipients list
DailyMed Link:SODIUM NITRITE at DailyMed
Drug patent expirations by year for SODIUM NITRITE
Recent Clinical Trials for SODIUM NITRITE

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

SponsorPhase
University of Alabama at BirminghamEarly Phase 1
University of Alabama at BirminghamPhase 1
National Institutes of Health (NIH)Phase 1

See all SODIUM NITRITE clinical trials

Medical Subject Heading (MeSH) Categories for SODIUM NITRITE
Anatomical Therapeutic Chemical (ATC) Classes for SODIUM NITRITE

US Patents and Regulatory Information for SODIUM NITRITE

SODIUM NITRITE is protected by three US patents.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Hope Pharms SODIUM NITRITE sodium nitrite SOLUTION;INTRAVENOUS 203922-001 Feb 14, 2012 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SODIUM NITRITE

See the table below for patents covering SODIUM NITRITE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3862007 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Subscribe
Canada 2752129 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Subscribe
Hungary E055250 ⤷  Subscribe
European Patent Office 3569237 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) ⤷  Subscribe
Lithuania 2395834 ⤷  Subscribe
Croatia P20191516 ⤷  Subscribe
Portugal 3569237 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SODIUM NITRITE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203431 CA 2015 00014 Denmark ⤷  Subscribe PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115
2465580 SPC/GB21/030 United Kingdom ⤷  Subscribe PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
0579826 SPC/GB02/042 United Kingdom ⤷  Subscribe 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
0145340 99C0005 Belgium ⤷  Subscribe PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
2203431 92666 Luxembourg ⤷  Subscribe PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2203431 15C0013 France ⤷  Subscribe PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2932970 18C1043 France ⤷  Subscribe PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

SODIUM NITRITE Market Analysis and Financial Projection Experimental

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

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