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Last Updated: December 11, 2025

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Sodium Chloride 0.9% In Sterile Plastic Container, and what generic alternatives are available?

Sodium Chloride 0.9% In Sterile Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER 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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  • What is the 5 year forecast for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER?
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Summary for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
Drug patent expirations by year for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
Pharmacology for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

US Patents and Regulatory Information for SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER sodium chloride SOLUTION FOR SLUSH;IRRIGATION 019319-002 May 17, 1985 RX Yes Yes ⤷  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 0.9% in Sterile Plastic Container

Last updated: August 2, 2025

Introduction

Sodium chloride 0.9% in sterile plastic containers, commonly referred to as normal saline, is a critical pharmaceutical product used worldwide in medical settings. It serves as a primary intravenous (IV) fluid for hydration, dilution of medications, and other clinical applications. The global market for this essential solution is shaped by dynamic healthcare demands, technological advancements, regulatory frameworks, and economic factors. Understanding these elements is vital for stakeholders aiming to capitalize on growth opportunities or anticipate market shifts.

Market Overview and Scope

The global sodium chloride 0.9% in sterile plastic containers market is categorized within the broader intravenous fluids and solutions sector, which was valued at approximately USD 8.4 billion in 2022. The segment’s consistent demand stems from its widespread use across hospitals, clinics, and emergency care facilities. Its simplicity, cost-effectiveness, and clinical efficacy sustain its prominence despite evolving medical innovations.

Key regions include North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. North America holds the largest market share, driven by high healthcare expenditure, regulatory compliance, and robust infrastructure. The Asia-Pacific region exhibits rapid growth, propelled by expanding healthcare access, increasing hospitalizations, and a rising prevalence of chronic diseases.

Market Drivers

1. Growing Healthcare Infrastructure and Hospitalizations

Surging hospital admissions globally, especially in developing nations, bolster demand for IV solutions like sodium chloride 0.9%. Investments in healthcare infrastructure—particularly in China, India, and Southeast Asia—are expanding distribution channels and access points [[1]].

2. Aging Population and Chronic Diseases

The increasing prevalence of chronic conditions such as diabetes, cancer, and cardiovascular diseases necessitates frequent hydration therapy and medication dilution, further bolstering market growth [[2]].

3. Rising Adoption of IV Therapy in Emergency and Critical Care

The COVID-19 pandemic underscored the reliance on IV fluids in critical care settings. While pandemic-related demand caused transient fluctuations, it ultimately embedded saline solutions as a staple in emergency response protocols [[3]].

4. Cost-Effectiveness and Clinical Familiarity

Normal saline’s longstanding clinical safety profile and affordability remain compelling for healthcare providers, especially in resource-limited settings, sustaining steady demand.

5. Innovations in Packaging and Delivery Systems

Advances in sterile container design, such as pre-filled, flexible bags, and enhanced sterilization techniques, improve safety and ease of use, influencing procurement decisions [[4]].

Market Constraints and Challenges

1. Regulatory Barriers and Quality Standards

Stringent import/export regulations, especially in regions like Europe and North America, require compliance with Good Manufacturing Practices (GMP) and drug safety standards, introducing barriers for new entrants [[5]].

2. Competitive Landscape and Price Pressures

Market saturation by established manufacturers, intense price competition, and procurement negotiations influence profit margins and expansion strategies.

3. Environmental Concerns and Sustainability

Environmental debates surrounding plastic waste from medical disposables put pressure on manufacturers to develop sustainable packaging options, potentially increasing R&D costs.

4. Limited Product Differentiation

As a standard solution, sodium chloride 0.9% in sterile containers faces limited product differentiation, restricting innovation-driven growth opportunities.

Regulatory Environment and Impact

Regulatory agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan) enforce product quality and safety standards, impacting manufacturing and distribution. Recent trends include adopting serialization and traceability measures to prevent contamination and counterfeiting [[6]]. These regulations influence market entry and operational costs but enhance product credibility.

Technological and R&D Trajectories

Emerging innovations include pre-filled syringe formulations, improved sterilization techniques, and environmentally friendly packaging. R&D investments aim to enhance container safety, extend shelf life, and reduce plastic waste [[7]].

Financial Outlook and Market Forecast

The sodium chloride 0.9% in sterile plastic container market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 5% from 2023 to 2030, reaching an estimated USD 12 billion by 2030. Growth drivers include:

  • Expansion in emerging markets
  • Increased healthcare expenditure
  • Technological advancements
  • Elevated demand owing to aging populations

Market participants are likely to experience increased revenues by investing in manufacturing capacity, diversifying product lines, and expanding regional presence, especially in Asia-Pacific and Latin America.

Competitive Landscape

Major players include Baxter International, Braun Melsungen AG, Hospira (a Pfizer company), B. Braun Melsungen AG, and local manufacturers in emerging economies. Strategic initiatives encompass acquisitions, partnerships, and investing in R&D to establish market dominance or penetrate new geographies [[8]].

Key Market Segments

  • By Packaging: Plastic bags, pre-filled syringes, infusion bottles
  • By Distribution Channel: Hospital pharmacies, retail pharmacies, online platforms
  • By End-user: Hospitals, clinics, ambulance/EMS services, home healthcare

Impact of COVID-19 and Pandemic Preparedness

COVID-19 amplified demand for IV solutions, underscoring the importance of supply chain resilience. Manufacturers focused on scaling production, ensuring safety compliance, and establishing diversified supplier networks to mitigate disruptions.

Supply Chain and Distribution Dynamics

Efficient logistics and inventory management are vital, given the product's short shelf life and sterilization requirements. The market has seen a shift towards regional manufacturing hubs to reduce dependency on global supply chains, ensuring timely supply during crises [[9]].

Environmental and Sustainability Considerations

Growing concerns about plastic waste and sustainability are prompting innovations in biodegradable materials, reusable packaging, and waste reduction strategies. However, regulatory and safety standards remain the primary focus, with environmental considerations increasingly influencing procurement policies.

Conclusion

The sodium chloride 0.9% in sterile plastic container market remains resilient, driven by indispensable clinical applications, expanding healthcare infrastructure, and aging demographics. While regulatory hurdles and environmental pressures pose challenges, technological innovation and strategic positioning offer growth avenues. Stakeholders investing in manufacturing capacity, R&D, and regional expansion stand to benefit from sustained demand, with a forecasted CAGR approximating 5% through 2030.


Key Takeaways

  • The global market is projected to reach USD 12 billion by 2030, fueled by rising healthcare demands and expanding infrastructure.
  • Emerging markets present significant growth opportunities due to increasing hospitalizations and healthcare investments.
  • Regulatory compliance and environmental sustainability are critical considerations for market participants.
  • Innovations in packaging and safety protocols enhance product adoption, especially in critical care environments.
  • Supply chain resilience is essential to meet fluctuating demand spikes, exemplified during the COVID-19 pandemic.

FAQs

1. What factors primarily influence the pricing of sodium chloride 0.9% in sterile plastic containers?
Pricing is influenced by raw material costs, manufacturing technology, regulatory compliance expenses, distribution logistics, and market competition. Price sensitivity in procurement also governs hospital and pharmacy purchasing decisions.

2. How do regulatory standards impact market entry for new manufacturers?
Strict regulatory standards require robust quality assurance, compliance with GMP, and product testing, elongating approval timelines and increasing compliance costs for new entrants.

3. What sustainable innovations are emerging in the packaging of saline solutions?
Biodegradable plastics, reusable container systems, and eco-friendly sterilization processes are under development to address environmental concerns and reduce plastic waste.

4. How has the COVID-19 pandemic affected the market’s growth trajectory?
The pandemic increased demand for IV solutions like saline, highlighting supply chain vulnerabilities and prompting investments in manufacturing expansion and inventory management.

5. What are the primary regional markets for sodium chloride 0.9% solutions?
North America and Europe dominate due to advanced healthcare systems, but rapid growth occurs in Asia-Pacific and Latin America driven by expanding healthcare infrastructure and increasing hospitalizations.


References

[1] Market Research Future, "Intravenous (IV) Fluid Market Trends," 2022.
[2] World Health Organization, "Chronic Disease Statistics," 2022.
[3] Johns Hopkins University, "Impact of COVID-19 on Healthcare Systems," 2022.
[4] Pharmaceutics International, "Packaging Innovations in IV Solutions," 2021.
[5] European Medicines Agency, "Regulatory Standards for IV Solutions," 2022.
[6] U.S. Food and Drug Administration, "Serialization & Traceability in Pharma," 2022.
[7] Research and Markets, "Sustainable Packaging in Medical Devices," 2023.
[8] GlobalData, "Competitive Landscape of IV Solutions," 2022.
[9] McKinsey & Company, "Supply Chain Strategies for Critical Medical Supplies," 2021.

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