Last Updated: May 3, 2026

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Sodium Chloride 0.9% In Plastic Container launch?

Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Baxter Hlthcare, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro. and is included in twenty-seven NDAs.

The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

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Summary for SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
US Patents:0
Applicants:15
NDAs:27

US Patents and Regulatory Information for SODIUM CHLORIDE 0.9% 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
Nephron SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;INJECTION 211968-001 Apr 23, 2020 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;INJECTION 019465-002 Jul 15, 1985 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 017514-001 Approved Prior to Jan 1, 1982 AT RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 016733-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 018314-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;INJECTION 018803-005 Jan 22, 2015 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;INJECTION 019465-001 Jul 15, 1985 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for Sodium Chloride 0.9% in Plastic Container

Last updated: February 3, 2026

Summary

Sodium chloride 0.9% in plastic containers is a widely used sterile intravenous (IV) fluid solution, predominantly for hydration, electrolyte replenishment, and medication delivery across healthcare settings worldwide. Its extensive clinical application, coupled with consistent demand and regulatory stability, makes it a mature segment with steady growth prospects. This report explores the current market landscape, investment opportunities, key market drivers and restraints, competitive dynamics, and financial forecasts, highlighting strategic considerations for stakeholders.


1. Market Overview

Product Specification and Industry Role

Parameter Details
Product Name Sodium Chloride 0.9% in Plastic Container
Use IV fluid therapy, medication dilution
Packaging Polyethylene, polyvinyl chloride (PVC), or polypropylene containers
Global Market Size (2022) USD 2.8 billion [1]
Projected CAGR (2023-2028) Approximately 4.5%-5%

Key Markets and Usage

Region Market Share (2022) Growth Rate (2023-2028) Key Drivers
North America ~40% 4% Aging population, chronic disease prevalence, hospital utilization
Europe ~25% 4.2% Healthcare infrastructure, regulatory stability
Asia-Pacific ~20% 6% Growing healthcare access, rising healthcare expenditure
Latin America & MEA ~10% 4.8% Expanding healthcare markets

2. Market Dynamics

Driving Factors

Factors Impact & Rationale
Thorough clinical utility Essential in hydration, medication dilution, and electrolyte correction ensures persistent demand.
Regulatory standardization WHO, FDA, EMA approvals, and GMP compliance provide regulatory confidence for manufacturers.
Healthcare infrastructure growth Especially in emerging markets, expanding hospital networks bolster consumption.
Aging and chronic disease trends Increased hospitalizations for conditions like dehydration, renal diseases augment demand.
Generic manufacturing and cost competitiveness Drives downward pricing pressures, widening access.

Market Restraints and Challenges

Restraints Impact & Rationale
Regulatory scrutiny Stringent quality standards increase compliance costs.
Supply chain disruptions COVID-19 disruptions impacted raw material sourcing and logistics.
Environmental concerns Plastic waste issues impose sustainability pressures.
Emerging generic competition Leads to pricing erosion, impacting profit margins.

Competitive Landscape

Major Players Market Share (Est.) Key Strategies
Baxter International Inc. ~30% Expansion in emerging markets, diversified product portfolio
Fresenius Kabi ~25% Focus on sterile manufacturing, supply chain optimization
B. Braun Melsungen AG ~15% Innovation, sustainable packaging solutions
Hospira (Part of Pfizer) ~10% Cost leadership, global reach
Others ~20% Regional players, generics, regional compliance strategies

3. Investment Opportunities and Market Entry Considerations

Product Development

  • Enhanced Packaging: Innovative, eco-friendly containers to comply with sustainability trends.
  • Sterility Assurance: Advanced sterilization techniques to minimize contamination risks.
  • Smart Packaging Technologies: Incorporation of IoT to monitor expiration, storage conditions.

Regulatory Pathways & Certifications

Region Regulatory Body Pathway Focus Timeframe (approx.)
US FDA (21 CFR Part 201) 510(k) clearance, GMP compliance 12-24 months
EU EMA & MDR Regulations CE marking, batch validation 18-30 months
China NMPA (CFDA) Registration dossier, Good Manufacturing Practices 24-36 months

Market Entry Strategies

  • Joint ventures with regional manufacturers.
  • Acquisition of existing manufacturing assets.
  • Partnerships with hospital chains and distributors.
  • Focus on emerging markets with unmet needs.

4. Financial Projections and Trends

Historical Financial Data

Year Global Sales (USD billion) CAGR (2018-2022) Major Revenue Contributors
2018 2.2 US (45%), Europe (25%), Others (30%)
2019 2.4 8.5% Increased hospital demand
2020 2.7 12.5% COVID-19 pandemic, increased ICU use
2021 2.8 3.7% Market stabilization post-pandemic
2022 2.8 0% (steady) Mature market, steady demand

Forecast for 2023-2028

Year Estimated Market Size (USD billion) CAGR Key Assumptions
2023 2.9 3.6% Continued hospital utilization, stable regulatory environment
2024 3.0 3.4% Growth in emerging markets, new product innovations
2025 3.2 4% Aging population drives hospital demand, increased chronic care
2026 3.3 3.1% Market saturation in mature regions, regulatory stability
2027 3.4 3.2% Expansion in Asian markets, sustainability initiatives
2028 3.5 3.1% Ongoing demand, moderate competition

Note: The steady growth reflects market maturity with incremental increases driven mainly by emerging markets and incremental innovation.


5. SWOT Analysis

Strengths Weaknesses
Established market with high demand Price competition and commoditization
Regulatory acceptance and standards Market saturation in developed regions
Broad application across healthcare Environmental impact of plastic waste
Opportunities Threats
Expansion into emerging markets Regulatory barriers, quality compliance costs
Innovation in eco-friendly packaging Supply chain vulnerabilities
Portfolio diversification (e.g., prep kits) Price erosion and margin pressure

6. Comparison with Alternative Saline Solutions

Aspect Sodium Chloride 0.9% Balanced Crystalloids (e.g., Lactated Ringer's) 0.9% Saline Alternatives
Cost Lower Slightly higher Variable, region-dependent
Applications Hydration, medication dilution, electrolyte correction Same, plus buffering capacity Less versatile
Stability & Handling Well-established Similar Similar
Patient outcomes Reliable Comparable Same

7. Regulatory and Policy Considerations

  • GMP Compliance: Must adhere to local manufacturing practices.
  • Environmental Regulations: Increasing pressure to reduce single-use plastics.
  • Pricing Regulations: Price controls in some jurisdictions impact profitability.
  • Trade Policies: Tariffs and import/export restrictions affect supply chain dynamics.
  • Quality Standards: ISO certifications (ISO 13485 for medical devices), local approvals vital for market access.

8. Key Drivers and Risks Summary

Drivers Risks
Global healthcare growth Increased regulatory scrutiny
Aging population Market competition erosion
Technological innovation Environmental sustainability constraints
Growing emerging markets Supply chain vulnerabilities

9. Key Market Players and Strategic Movements

Company Name Strategic Actions
Baxter International Inc. Diversification, sustainability, capacity expansion
Fresenius Kabi Strengthening supply chain, eco-friendly packaging initiatives
B. Braun Melsungen AG Product innovation, regulatory compliance focus
Hospira (Pfizer) Cost leadership, expanding regional manufacturing

10. Investment Outlook & Recommendations

  • Stable Investment: Due to its mature, essential product profile, investing in manufacturing or distribution capabilities for sodium chloride 0.9% offers stable, regulated cash flows.
  • Innovation Focus: Opportunities to differentiate via sustainable packaging, smart containers, and enhanced sterilization.
  • Emerging Markets Entry: High-growth potential in Asia, Africa, and Latin America warrants strategic deployment.
  • Collaboration & Licensing: Partnerships with regional OEMs, especially in markets with regulatory complexity.

Key Takeaways

  • The sodium chloride 0.9% market presents consistent demand driven by universal clinical applications.
  • Growth is driven primarily by emerging market expansion, aging populations, and hospital utilization.
  • Market competition remains intense, with a focus on cost, quality, and sustainability.
  • Regulatory compliance and environmental sustainability are key challenges and opportunities.
  • Financial growth remains stable but moderate (projected CAGR of approximately 3.1%-4.5%).

FAQs

Q1. What is the primary growth driver for sodium chloride 0.9%?
A1. Increasing demand for IV hydration solutions and electrolyte management, especially in aging populations and emerging markets.

Q2. How does environmental sustainability impact the market?
A2. Growing environmental concerns over plastic waste are pushing manufacturers toward eco-friendly packaging solutions, potentially increasing costs but also opening innovation avenues.

Q3. What regions offer the highest investment potential?
A3. Asia-Pacific and Latin America show high growth prospects due to expanding healthcare infrastructure and rising healthcare expenditure.

Q4. Are there regulatory differences affecting market entry?
A4. Yes, developers must navigate regional standards such as FDA (US), EMA (Europe), and NMPA (China), which influence approval timelines and compliance costs.

Q5. How has the COVID-19 pandemic influenced demand?
A5. The pandemic has temporarily increased demand due to ICU and hospitalization needs, but long-term growth remains steady, as demand for IV fluids is fundamental.


References

[1] MarketsandMarkets, "IV Fluids Market by Product (Sodium Chloride, Dextrose), Application (Hydration, Medication Delivery), End-User (Hospitals, Clinics), Region - Global Forecast to 2028," 2022.

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