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Last Updated: December 19, 2025

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% In Plastic Container, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.3% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.

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Questions you can ask:
  • What is the 5 year forecast for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% 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 DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-003 Approved Prior to Jan 1, 1982 DISCN 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 Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% in Plastic Containers

Last updated: July 31, 2025

Introduction

The infusion of Dextrose 5% combined with Sodium Chloride 0.45% and Potassium Chloride 0.3% in plastic containers forms a vital component of fluid therapy in hospitals globally. This combination, often marketed as balanced crystalloids, supports hydration, electrolyte balance, and calorie provision, especially in critical care settings. Given its widespread clinical utility, understanding the market dynamics and financial trajectory of this pharmaceutical formulation is crucial for stakeholders ranging from manufacturers to investors.

Market Overview

The global infusion fluid market, which encompasses solutions like Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3%, was valued at approximately USD 2.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 7% through 2030, driven by rising healthcare expenditures, expanding hospital infrastructure, and increased prevalence of chronic diseases requiring parenteral nutrition and hydration therapy[^1].

The segment featuring combination fluids in plastic containers dominates due to their convenience, safety, and ease of disposal. The shift from glass to plastic bottles—primarily polyethylene and polypropylene—has contributed significantly to market expansion by reducing breakage risks and simplifying logistics.

Market Drivers

Growing Global Healthcare Demand

The burgeoning global healthcare market, especially in emerging economies such as India, China, and Brazil, underpins the demand for infusion solutions. Populations aged over 60 years exhibit increased incidence of surgeries, dehydration issues, and electrolyte imbalances, propelling market growth[^2].

Hospital Infrastructure Expansion

Investments in hospital infrastructure, including ICU beds and outpatient infusion centers, enhance the utilization of infusion solutions. Regulatory approvals for new formulations further favor market expansion[^3].

Advancements in Packaging and Distribution

Plastic container innovations, such as flexible bags and pre-filled syringes, improve patient safety and decrease contamination risks, stimulating demand. The widespread adoption of portable infusion devices increases the preference for ready-to-use plastic containers.

Rising Chronic Disease Burden

Diabetes, renal disorders, and gastrointestinal diseases requiring fluid and electrolyte correction contribute significantly to the consumption of these solutions[^4].

Market Challenges

Regulatory Hurdles

Stringent regulations concerning manufacturing practices, labeling, and quality standards—particularly in markets like the U.S. (FDA), Europe (EMA), and others—pose compliance challenges[^5].

Pricing Pressures

Generic competition and price regulation policies threaten profitability for manufacturers, especially in price-sensitive markets like India and Southeast Asia[^6].

Supply Chain Disruptions

Global disruptions, including pandemics and geopolitical tensions, impact raw material procurement, manufacturing schedules, and distribution channels.

Financial Trajectory and Revenue Projections

Revenue Streams and Market Segmentation

The primary revenue source derives from hospital supplies and bulk procurement via tenders. The critical segments include:

  • By Application: Clinical hydration, nutrition, emergency medicine, surgical procedures.
  • By Packaging: Plastic bottles (most prevalent), pre-filled syringes, flexible bags.
  • By Geography: North America leads with approximately 40% market share, followed by Europe; Asia-Pacific shows the highest growth potential due to expanding healthcare infrastructure.

Pricing Trends

Average market prices for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% in plastic containers range between USD 1.50 and USD 3.00 per liter, influenced by factors such as formulation complexity, packaging, and regulatory overhead.

Forecasted Revenue Growth

Based on current growth rates, the market is expected to reach USD 3.7 billion by 2030, representing a CAGR of 7%. The Asia-Pacific segment is projected to outpace others with a CAGR exceeding 8%, owing to increased healthcare investments and rising prevalence of electrolyte imbalance conditions.

Profit Margins and Investment Outlook

Profit margins for manufacturers remain between 15-25%, impacted by raw material costs (notably bulk chemicals), manufacturing expenses, and regulatory compliance costs. Investment in R&D for advanced packaging and stabilized formulations can enhance profitability.

Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Pfizer Inc., Hospira (a Pfizer division), and Fresenius Kabi. They compete through product innovation, strategic alliances, and regional expansion.

Regional challengers focus on local manufacturing capabilities with price advantages, while multinational firms emphasize quality assurance and regulatory compliance.

Regulatory and Policy Impact

Global regulatory bodies enforce strict standards. The U.S. pharmacopeia standards, European pharmacopoeia, and WHO guidelines influence formulation, sterility, and packaging practices[^7].

Policy shifts favoring local manufacturing and patent expirations for certain formulations may alter competitive dynamics, presenting opportunities for new entrants.

Future Outlook: Opportunities and Risks

Opportunities

  • Development of electrolyte solutions with enhanced stability and extended shelf life.
  • Adoption of intelligent packaging with tracking and safety features.
  • Expansion into emerging markets driven by healthcare infrastructure growth.
  • Integration of personalized medicine trends in infusion therapy.

Risks

  • Stringent regulatory barriers could delay product launches.
  • Price-sensitive markets threaten profitability.
  • Fluctuations in raw material costs, including chemicals and plastics.
  • Preference shifts towards alternative therapies or fluid formulations.

Key Takeaways

  • The global infusion solution market for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% in plastic containers is poised for steady growth driven by rising healthcare needs, infrastructure upgrades, and technological innovations.
  • Asia-Pacific presents the highest growth opportunities, emphasizing local manufacturing and regulatory adaptation.
  • Competitive differentiation hinges on formulation stability, packaging innovation, and compliance excellence.
  • Price pressures necessitate operational efficiencies and strategic alliances.
  • Regulatory landscapes require continuous vigilance; compliance remains pivotal to market access and revenue stability.

Conclusion

The market for Dextrose 5%, Sodium Chloride 0.45%, and Potassium Chloride 0.3% in plastic containers is positioned for consistent expansion. Stakeholders should capitalize on regional growth trends, invest in packaging and formulation innovations, and proactively navigate regulatory environments to optimize their financial trajectories.


FAQs

Q1: What are the primary factors influencing the pricing of infusion solutions in plastic containers?
A1: Raw material costs (chemicals and plastics), manufacturing expenses, regulatory compliance, packaging innovations, and competitive market dynamics primarily influence pricing.

Q2: How do regulatory standards impact the market for these infusion solutions?
A2: Regulatory standards ensure product safety, quality, and sterility. They influence manufacturing practices, packaging, labeling, and approval timelines, directly affecting market entry and profitability.

Q3: Which geographic regions offer the most growth potential?
A3: Asia-Pacific, driven by expanding healthcare infrastructure and increasing disease prevalence, offers significant growth opportunities, followed by Latin America and Africa.

Q4: How can manufacturers differentiate their infusion solutions in a competitive market?
A4: Through innovations in packaging (e.g., pre-filled syringes), formulation stability, customization for specific clinical needs, and compliance with stringent quality standards.

Q5: What are the main risks associated with investing in this market?
A5: Regulatory hurdles, price pressures, raw material cost fluctuations, supply chain disruptions, and competitive commoditization pose key risks.


References

[^1]: MarketsandMarkets, "Infusion Therapy Market," 2022.
[^2]: World Health Organization, "Global Health Estimates," 2021.
[^3]: Grand View Research, "Hospital Infrastructure and Infusion Solutions," 2022.
[^4]: Statista, "Prevalence of Chronic Diseases," 2022.
[^5]: U.S. Food and Drug Administration (FDA), "Regulatory Guidelines," 2022.
[^6]: Invest India, "Pharmaceutical Industry in India," 2022.
[^7]: WHO Pharmaceutical Guidelines, 2021.

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