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Last Updated: December 28, 2025

SODIUM CHLORIDE 23.4% Drug Patent Profile


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Which patents cover Sodium Chloride 23.4%, and when can generic versions of Sodium Chloride 23.4% launch?

Sodium Chloride 23.4% is a drug marketed by Fresenius Kabi Usa, Hospira, and Abraxis Pharm. and is included in five NDAs.

The generic ingredient in SODIUM CHLORIDE 23.4% is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

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Summary for SODIUM CHLORIDE 23.4%
US Patents:0
Applicants:3
NDAs:5
Finished Product Suppliers / Packagers: 3
DailyMed Link:SODIUM CHLORIDE 23.4% at DailyMed
Drug patent expirations by year for SODIUM CHLORIDE 23.4%
Pharmacology for SODIUM CHLORIDE 23.4%

US Patents and Regulatory Information for SODIUM CHLORIDE 23.4%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa SODIUM CHLORIDE 23.4% sodium chloride INJECTABLE;INJECTION 212248-001 Apr 28, 2021 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira SODIUM CHLORIDE 23.4% sodium chloride SOLUTION;INTRAVENOUS 018897-003 Jun 18, 2020 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa SODIUM CHLORIDE 23.4% sodium chloride INJECTABLE;INJECTION 217796-001 Jul 11, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Sodium Chloride 23.4%

Last updated: July 31, 2025

Introduction

Sodium chloride 23.4% solutions are predominantly used in medical, pharmaceutical, and industrial sectors, notably in intravenous (IV) therapy, dialysis, and as a buffering agent for manufacturing processes. As a critical commodity within healthcare infrastructure and pharmaceutical manufacturing, understanding the market dynamics and financial trajectory of this chemical presents opportunities and risks aligned with technological advances, regulatory landscapes, and global health trends.

This report analyzes the current and projected market environment for sodium chloride 23.4%, examining supply-demand patterns, regulatory influences, competitive landscape, and future growth prospects. The goal is to furnish decision-makers with data-driven insights into the valuation and strategic positioning of this crucial compound.

Market Overview and Key Applications

Sodium chloride (NaCl), at a concentration of 23.4%, primarily serves as an isotonic saline solution for intravenous infusion, a foundational element in hospital care—used for hydration, electrolyte balance, and drug delivery. Additionally, the compound functions as a buffer in pharmaceutical formulations, a disinfectant, and a raw material in chemical manufacturing such as the production of chemicals like sodium hydroxide and hydrochloric acid.

The global market for sodium chloride solutions is segmented into healthcare applications, industrial use, and research sectors. Recent advancements in medical technology and increasing healthcare expenditure promote steady demand, with regional disparities reflecting infrastructure development, healthcare access, and regulation.

Market Dynamics

Supply and Production Trends

Major producers of sodium chloride 23.4% solutions include large-scale chemical manufacturing companies, regional salt producers, and pharmaceutical suppliers. The suppliers often integrate vertically, with primary raw material sources being salt mines and seawater evaporation ponds, primarily in regions such as North America, China, Australia, and parts of Europe.

The capacity of global production is influenced by the availability of salt reserves, environmental regulations concerning saline extraction, and advancements in salt processing technologies. Notably, innovations in membrane-based purification and extraction methods have improved yield efficiency, reducing costs and environmental footprint.

Demand Drivers

  • Healthcare Infrastructure Expansion: Increasing global healthcare access, particularly in emerging economies, drives demand for saline solutions for IV therapy.
  • Aging Population: The global aging demographic requires more hydration and electrolyte management, boosting consumption.
  • Pharmaceutical Manufacturing Growth: Heightened use in drug formulation and manufacturing energizes demand, especially amidst a rising pipeline of biologics requiring saline compatibility.
  • Industrial Applications: The chemical sector’s growth in regions like Asia fuels demand for salt-based raw materials, indirectly impacting sodium chloride concentrate supply.

Regulatory Environment

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and equivalent local authorities oversee the safety, quality, and manufacturing practices of pharmaceutical-grade sodium chloride solutions. Stringent compliance standards impact production costs but assure market stability.

Environmental regulations influence salt production, limiting environmental emissions, wastewater management, and resource extraction. These constraints can increase costs but also incentivize technological innovation within the supply chain.

Competitive Landscape

The market features both multinational conglomerates—such as Baxter International, Hospira, and local producers in China and India—competing on price, quality, and regulatory compliance. Risk factors include raw material price volatility, geopolitical considerations impacting supply chains, and technological barriers to entry.

Emerging entrants focus on optimizing production efficiency, certifying pharmaceutical-grade compliance, and expanding regional distribution networks to capitalize on rising demand.

Price Trends and Financial Outlook

Historically, sodium chloride 23.4% solutions have maintained relatively stable pricing given their essential medical role and manufacturing ubiquity. However, fluctuations in raw salt prices, transportation costs, and regulatory compliance expenses can cause short-term volatility.

Forecasts suggest a modest CAGR (Compound Annual Growth Rate) of approximately 3-5% over the next five years, driven by rising healthcare expenditure and pharmaceutical manufacturing capacity. Price stability is expected to persist due to the inelastic nature of demand in critical healthcare applications.

Future Growth Opportunities and Challenges

Opportunities

  • Innovation in Production: Advances in membrane filtration and salt extraction reduce environmental impact and costs, enhancing margin prospects.
  • Expanding Emerging Market Penetration: Increasing healthcare infrastructure investments in Asia, Africa, and South America open new demand channels.
  • Product Diversification: Development of specialized isotonic solutions, sterile formulations, and integrated pharmaceutical kits can add value.
  • Regulatory Harmonization: Global efforts toward standardization streamline manufacturing and reduce compliance costs, facilitating market entry.

Challenges

  • Environmental Regulations: Stricter environmental standards may constrain raw material extraction and increase operating costs.
  • Raw Material Price Volatility: Salt prices fluctuate based on global supply-demand dynamics, impacting profit margins.
  • Competition from Alternative Solutions: Growing interest in alternative electrolyte formulations or synthetic analogs could threaten market share.

Financial Trajectory Analysis

The financial outlook for sodium chloride 23.4% solutions aligns with global healthcare spending trends. Companies with established production, efficient supply chain management, and compliance with regulatory standards are positioned to capitalize on growth opportunities.

Investors and manufacturers should anticipate steady revenue streams, but with caution around input cost volatility and environmental compliance expenditures. Profitability linked to scale efficiencies and technological improvements will be vital in maintaining competitive advantage.

In the context of an expanding global healthcare footprint, particularly in emerging markets, the market is poised for consistent growth with incremental margin improvements driven by process innovation and regulatory harmonization.

Key Takeaways

  • Steady Demand: The critical role of sodium chloride 23.4% in healthcare ensures a stable demand base, with anticipated CAGR of 3-5% over the next five years.
  • Supply Chain Resilience: Vertical integration and technological innovation in salt extraction bolster supply security and cost competitiveness.
  • Regulatory and Environmental Factors: Compliance demands will influence production costs; strategic adaptation to evolving regulations is essential.
  • Market Penetration in Emerging Economies: Rising healthcare infrastructure in developing regions offers significant expansion opportunities.
  • Innovation and Diversification: Technological advancements and product development can drive margins and entry barriers.

FAQs

1. What are the primary factors driving demand for sodium chloride 23.4% solutions?
Demand is primarily driven by expanding global healthcare infrastructure, aging populations requiring electrolyte management, growth in pharmaceutical manufacturing, and industrial applications of salt derivatives.

2. How do environmental regulations impact sodium chloride production?
Environmental regulations necessitate sustainable extraction and processing practices, increasing costs but encouraging technological innovations that reduce environmental footprints and ensure regulatory compliance.

3. What regions are leading in sodium chloride 23.4% market supply?
North America, China, Australia, and Europe are leading due to large salt reserves, established manufacturing infrastructure, and high pharmaceutical standards.

4. What technological innovations are influencing the market?
Membrane-based extraction processes and eco-friendly purification methods reduce costs and environmental impact, improving supply chain efficiency.

5. What are the key risks affecting the financial trajectory of sodium chloride 23.4%?
Price volatility of raw materials, regulatory compliance costs, environmental restrictions, and competition from alternative electrolytes pose significant risks.


Sources
[1] MarketsandMarkets, "Global Salt Market," 2022.
[2] Pharma Intel, "Medical saline solutions supply chain insights," 2021.
[3] IndustryARC, "Chemical manufacturing and environmental regulations," 2022.
[4] Statista, "Healthcare infrastructure growth," 2023.
[5] Smith & Co. Market Analytics, "Pharmaceutical ingredients market report," 2022.

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