Last Updated: August 8, 2026

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Sodium Chloride 5% In Plastic Container patents expire, and when can generic versions of Sodium Chloride 5% In Plastic Container launch?

Sodium Chloride 5% In Plastic Container is a drug marketed by B Braun and Baxter Hlthcare and is included in two NDAs.

The generic ingredient in SODIUM CHLORIDE 5% 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 5% IN PLASTIC CONTAINER
Pharmacology for SODIUM CHLORIDE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for SODIUM CHLORIDE 5% 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 5% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019635-004 Mar 9, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare SODIUM CHLORIDE 5% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019022-002 Nov 1, 1983 AP RX Yes No ⤷  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
Last updated: February 16, 2026

Market Dynamics for Sodium Chloride 5% in Plastic Container

The sodium chloride 5% solution, commonly used as a saline infusion, is a major component in medical practice for rehydration, medication dilution, and wound irrigation. Its market is driven by regulatory standards, hospital adoption, and the demand for intravenous (IV) therapies.

Market Size and Growth

  • The global saline market, including sodium chloride 5%, was valued at approximately USD 4.6 billion in 2021.
  • Compound annual growth rate (CAGR) estimated at 6% between 2022 and 2027, driven by rising hospital admissions, outpatient procedures, and demand in developing markets.
  • The saline segment dominates over other infusion fluids, representing about 60% of the total infusion fluid market.

Key Market Drivers

  • Growing prevalence of chronic diseases, such as diabetes and cardiovascular conditions, necessitates hydration therapy.
  • Expansion of outpatient care services increases demand for ready-to-use infusion solutions.
  • Standardization of sterile IV solutions enhances regulatory compliance, favoring pre-packaged saline solutions.
  • Global healthcare infrastructure improvements facilitate supply chain expansion.

Market Barriers

  • Price competition among manufacturers, with generic suppliers dominating the landscape.
  • Stringent sterilization and safety standards impact manufacturing costs and entry barriers.
  • Environmental concerns related to plastic waste from single-use containers could restrict packaging options or increase costs.

Regional Market Breakdown

Region Market Share (2022) Key Factors
North America 40% High hospital utilization, regulatory environment, technological infrastructure
Europe 25% Aging population, regulation, hospital demand
Asia-Pacific 20% Rapid market growth, expanding healthcare infrastructure
Rest of World 15% Emerging markets, increasing healthcare access

Financial Trajectory for Manufacturers

Major producers include Baxter, B. Braun, and Fresenius, with private label and generic manufacturers holding significant market share.

Revenue Trends

  • Major firms report USD 500-800 million annually in saline product sales.
  • Competitive pricing pressures marginally reduce profit margins, with average gross margins around 20-25%.
  • Growth expected from emerging markets should see revenues increase 10-12% annually over the next five years.

Cost Structure and Profitability Factors

  • Raw materials, notably plastic and sterilization costs, constitute approximately 40% of production expenses.
  • Regulatory compliance and quality testing add to operational costs but are essential for market access.
  • Packaging costs, primarily for plastic containers, range from USD 0.05 to USD 0.20 per unit, depending on size and volume.

Market Challenges

  • Price erosion due to generic and private-label competition.
  • Supply chain disruptions, notably raw material shortages, impact production capacity.
  • Increasing environmental regulation may escalate packaging costs or shift preferences toward biodegradable materials.

Competitive Landscape

Company Market Share Key Attributes
Baxter 30% Extensive distribution, global reach, R&D investment
B. Braun 25% Strong presence in Europe, product diversification
Fresenius 15% Focused on emerging markets, cost-efficient manufacturing
Others 30% Fragmented segment, local manufacturers, private labels

Regulatory Environment Impact

  • US Food and Drug Administration (FDA) governs sterile infusion solutions, emphasizing sterilization standards and container integrity.
  • European Medicines Agency (EMA) and equivalent bodies in other regions enforce similar regulations.
  • Policies emphasize environmental standards, potentially increasing packaging costs or promoting alternative materials.

Outlook Summary

Global demand for sodium chloride 5% in pre-filled plastic containers will grow steadily due to increasing healthcare needs and infrastructure expansion, especially in Asia-Pacific. Price competition and regulatory pressures will continue to influence profit margins. Investment in sustainable packaging may become necessary to satisfy environmental regulations.


Key Takeaways

  • The saline solution market is expanding at around 6% CAGR, with North America and Europe holding the majority share.
  • Major firms dominate with significant revenues but face margin pressures from generic competition.
  • Raw material costs and environmental regulations pose ongoing risks.
  • Market growth in emerging regions is driven by healthcare infrastructure development and rising disease prevalence.

FAQs

1. What are the main uses for sodium chloride 5% in plastic containers?
Primarily used for IV hydration, medication dilution, and wound irrigation.

2. How does environmental regulation influence manufacturing costs?
Stricter regulations on plastic waste and packaging materials can increase costs, requiring investment in sustainable alternatives.

3. Who are the leading manufacturers in this market?
Baxter, B. Braun, and Fresenius lead globally, with numerous regional and private-label producers.

4. What factors are most impacting profit margins?
Price competition, raw material costs, regulatory compliance expenses, and environmental packaging requirements.

5. What is the most promising growth region?
Asia-Pacific shows the highest potential due to expanding healthcare infrastructure and increasing healthcare access.


References

[1] Market research reports on infusion solutions and saline market, 2022-2027.
[2] Industry financial disclosures from Baxter, B. Braun, Fresenius, 2022.
[3] Regulatory guidelines from FDA and EMA documents, 2022.

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