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Last Updated: December 12, 2025

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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When do Sodium Chloride 0.45% In Plastic Container patents expire, and when can generic versions of Sodium Chloride 0.45% In Plastic Container launch?

Sodium Chloride 0.45% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Miles, and Otsuka Icu Medcl. and is included in eleven NDAs.

The generic ingredient in SODIUM CHLORIDE 0.45% IN 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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Summary for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018184-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018090-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 208122-001 Jul 23, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 017864-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635-001 Mar 9, 1988 AP RX Yes 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 0.45% in Plastic Container

Last updated: July 29, 2025

Introduction

Sodium chloride (NaCl) 0.45% in plastic containers is a sterile, isotonic saline solution primarily used for intravenous (IV) therapy, wound irrigation, and other medical applications. Its widespread adoption in hospitals, clinics, and home healthcare settings underscores its significance in the sterile saline segment of the pharmaceutical market. Understanding the evolving market dynamics and forecasting the financial trajectory of this commodity unveils key insights for stakeholders ranging from manufacturers to investors.

Market Overview

The global sterile saline market, including sodium chloride solutions, was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030 [1]. This growth reflects expanding healthcare infrastructure, increasing prevalence of chronic diseases requiring infusion therapy, and rising adoption of home healthcare services.

Within this landscape, sodium chloride 0.45% in plastic containers occupies a niche often characterized by its use in osmotic diuresis, wound cleansing, and hypotonic therapy. Its role is critical owing to its specific isotonic or hypotonic properties that cater to nuanced clinical needs.

Market Drivers

1. Growth in Hospital and Healthcare Infrastructure

Developing nations are witnessing robust expansion in healthcare facilities, augmenting the demand for sterile saline solutions. The World Health Organization reports health infrastructure investments boosting the availability and accessibility of IV fluids, including sodium chloride solutions [2].

2. Rising Incidence of Chronic Diseases

Chronic conditions such as cardiovascular diseases, dehydration, and electrolyte imbalances attribute to increased infusion therapy requirements. The prevalence of diabetes alone increased globally by 10.4% from 2019 to 2021, elevating the need for IV electrolytes [3].

3. Hospitals’ Shift Toward Cost-Effective, Single-Use Plastic Packaging

The industry’s transition from glass to plastic containers has enhanced safety, portability, and inventory management. Plastic containers reduce breakage and contamination risks, further propelling their adoption [4].

4. Growth of Home Healthcare and Ambulatory Care

With advancements in portable infusion devices and home-based care models, the demand for pre-filled, ready-to-use sterile saline solutions like sodium chloride 0.45% in plastic containers surges outside traditional hospital settings.

5. Increased Regulatory Approvals and Manufacturing Innovations

Regulatory agencies such as the FDA and EMA are streamlining approval pathways for sterile saline products. Innovations in manufacturing, sterilization, and packaging have enhanced product shelf-life, driving market consistency and expansion.

Market Challenges

1. Competitive Landscape and Price Sensitivity

Mature markets are characterized by intense pricing pressures and commoditization. The low-profit margins on saline solutions restrict investments in innovation, impacting industry profitability.

2. Stringent Regulatory Compliance

Ensuring compliance with Good Manufacturing Practices (GMP) and quality standards entails substantial investment, potentially constraining smaller players and new entrants.

3. Environmental Concerns and Sustainability Initiatives

Plastic waste from single-use containers faces scrutiny regarding environmental impact. Regulatory and corporate sustainability commitments could influence packaging choices and impact production costs.

Key Market Players and Competitive Dynamics

Major manufacturers include Baxter International, B. Braun Melsungen AG, Hospira (a Pfizer subsidiary), and Fresenius Kabi. These firms primarily focus on manufacturing, sterilization, and distribution efficiencies.

Market differentiation mainly stems from cost leadership, supply chain robustness, and compliance capabilities. Strategic alliances, capacity expansions, and technological innovations serve as competitive levers.

Financial Trajectory and Investment Outlook

Revenue Projections and Growth Opportunities

The sterile saline solutions segment is anticipated to expand in tandem with healthcare expenditure growth. Emerging markets, particularly in Asia-Pacific, are projected to lead this expansion, facilitated by government health initiatives and increasing private sector investments [5].

The market for sodium chloride 0.45% in plastic containers, specifically, is expected to grow at a CAGR of 5.5% to 6.5% from 2023 to 2030, driven by increased adoption in wound management and outpatient infusion therapy.

Pricing Trends and Margin Analysis

Given the commoditized nature of saline solutions, pricing remains highly competitive. Market entrants competing on scale and supply chain efficiency tend to maintain margins around 10-15%, with larger players leveraging economies of scale.

Innovation in sterilization techniques (e.g., aseptic filling, closed-system manufacturing) may provide marginal cost savings and quality improvements, positively impacting margins over time.

Impact of Regulatory and Environmental Policies

Adherence to evolving environmental standards—such as bans on single-use plastics or mandates for biodegradable packaging—could impose additional costs. Conversely, investments in sustainable packaging may open new market segments and bolster brand reputation.

Risks and Uncertainties

Market volatility stems from geopolitical factors affecting supply chains, raw material price fluctuations (notably plastic resins), and regulatory changes. The ongoing COVID-19 pandemic underscores supply chain fragility but also highlights the essential nature of sterile saline solutions.

Regional Market Dynamics

  • North America: Largest market share, driven by high healthcare spending, advanced infrastructure, and regulatory standards.
  • Europe: Steady growth, with a focus on sustainability initiatives impacting packaging.
  • Asia-Pacific: Fastest-growing region, propelled by increasing healthcare access, urbanization, and expanding manufacturing bases.
  • Latin America and Africa: Emerging markets with opportunities driven by healthcare infrastructure development, though facing logistical and regulatory hurdles.

Strategic Implications for Stakeholders

  • Manufacturers should prioritize scale and supply chain resilience to navigate price pressures.
  • Investors should monitor regulatory policies and environmental standards that could influence costs.
  • Healthcare Providers should evaluate the benefits of bulk procurement and sustainable packaging options.
  • Regulators can facilitate market growth by streamlining approval pathways and enforcing environmental standards.

Key Takeaways

  • The global market for sodium chloride 0.45% in plastic containers is poised for steady growth, driven by increasing healthcare infrastructure and chronic disease management.
  • Market dynamics favor large-scale manufacturers with robust supply chains, cost efficiencies, and commitment to regulatory compliance.
  • Sustainability concerns pose both challenges and opportunities—potentially increasing costs but also incentivizing innovation and brand differentiation.
  • Geographical diversification, notably in developing regions, offers significant growth potential but requires overcoming logistical and regulatory barriers.
  • Technological advances, including improved sterilization and eco-friendly packaging, will influence future competitiveness and profitability.

FAQs

1. What differentiates sodium chloride 0.45% in plastic containers from other saline solutions?
It is specifically formulated for applications requiring a hypotonic, isotonic solution, particularly in wound care and infusion therapy. The plastic container enhances safety, portability, and storage convenience compared to glass alternatives.

2. How does environmental sustainability impact the sterile saline market?
Environmental concerns about plastic waste are prompting industry shifts toward biodegradable packaging and recycling initiatives, which may increase manufacturing costs but also open new markets and enhance corporate sustainability profiles.

3. What are the primary growth regions for sodium chloride 0.45% in plastic containers?
While North America and Europe are mature markets, strong growth is anticipated in Asia-Pacific, Latin America, and Africa, driven by expanding healthcare infrastructure.

4. How do regulatory standards influence market dynamics?
Stringent approval processes for sterile products require significant compliance investments, influencing entry barriers, pricing strategies, and product quality standards across regions.

5. What is the future outlook for pricing and margins?
Pricing pressure will likely persist due to commoditization; however, technological innovations and supply chain efficiencies may help sustain healthy margins for large players.

References

[1] MarketsandMarkets. (2022). Sterile Saline Market Forecast.
[2] World Health Organization. (2021). Global Healthcare Infrastructure Reports.
[3] International Diabetes Federation. (2022). Diabetes Atlas.
[4] Smithers Pira. (2021). Packaging Trends in Healthcare.
[5] Research and Markets. (2023). Asia-Pacific Medical Packaging Market.


This article aims to empower healthcare stakeholders, manufacturers, and investors with strategic insights into the market dynamics and financial prospects of sodium chloride 0.45% in plastic containers.

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