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Last Updated: December 12, 2025

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 10% And Sodium Chloride 0.33% In Plastic Container patents expire, and when can generic versions of Dextrose 10% And Sodium Chloride 0.33% In Plastic Container launch?

Dextrose 10% And Sodium Chloride 0.33% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

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Summary for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.33% 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 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-013 Feb 24, 1988 RX 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 10% and Sodium Chloride 0.33% in Plastic Containers

Last updated: August 4, 2025


Introduction

The pharmaceutical segment involving injectable solutions such as Dextrose 10% combined with Sodium Chloride 0.33% in plastic containers exemplifies a vital healthcare component, primarily used for intravenous (IV) therapy. These solutions serve critical roles in rehydration, electrolyte balancing, and nutritional support, especially within hospital settings. This analysis explores the current market landscape, key drivers, challenges, and future financial trajectories associated with this formulation.


Market Overview

The global market for IV hydration solutions, including Dextrose and Sodium Chloride combinations, is on an upward trajectory driven by increasing hospitalization rates, rising incidences of dehydration, and burgeoning outpatient infusion therapies. The segment falls under the broader isotonic IV fluids category, which is projected to grow at a compound annual growth rate (CAGR) of approximately 6% over the next five years [1].

Dextrose 10% and Sodium Chloride 0.33% specifically cater to nutritional replenishment and electrolyte management in clinical and post-surgical settings. Its usage spans hospitals, emergency care units, and outpatient clinics.


Market Drivers

1. Growing Healthcare Infrastructure and Hospitalization Rates

Developed and emerging markets are investing heavily in healthcare infrastructure expansion. The increasing prevalence of chronic diseases, infections, and surgical procedures enhances demand for IV fluids. The World Health Organization (WHO) reports that hospitalization rates worldwide are rising, with IV therapies accounting for 30-40% of inpatient treatments [2].

2. Rising Incidence of Dehydration and Electrolyte Imbalances

Dehydration due to illnesses such as diarrhea, cholera, and COVID-19 has underscored the necessity for efficient rehydration solutions. According to the CDC, dehydration remains a leading cause of morbidity globally, boosting the prescription and supply of IV fluids [3].

3. Preference for Plastic, Single-Use Containers

Plastic, single-use containers for IV solutions are favored for minimizing cross-contamination, ease of storage, and compatibility with automated infusion systems. The shift from glass to plastic has been accelerated during the COVID-19 pandemic, emphasizing safety and efficiency.

4. Advances in Formulation and Packaging

Innovations in sterile plastic container manufacturing, including pre-sterilized, ready-to-use solutions, have expanded market accessibility, especially in outpatient and emergency settings.

Market Challenges

1. Regulatory and Quality Assurance

Stringent regulatory oversight in regions such as the US (FDA), Europe (EMA), and Asia (PMDA) necessitates rigorous compliance, delaying product approval and increasing costs for manufacturers.

2. Cost-Pressure and Competitive Landscape

Pricing pressures from healthcare payers and hospitals, compounded by surge in generic manufacturers, compel firms to optimize production costs while maintaining quality standards.

3. Supply Chain Disruptions

Global disruptions, notably during the COVID-19 pandemic, affected raw material supplies, impacting manufacturing continuity and pricing stability.


Financial Trajectory

1. Market Growth Projections

The market for Dextrose 10% and Sodium Chloride 0.33% in plastic containers is expected to expand at a CAGR of 5-6% over the next five years [1]. This growth is driven by expanding healthcare needs in emerging markets and continued technological improvements.

2. Revenue Streams

Revenues predominantly derive from hospital sales, with outpatient clinics and long-term care facilities constituting secondary channels. Premium formulations with enhanced stability, sterilization, and packaging command higher margins, though price competition is intense.

3. Pricing Trends

Manufacturers face downward pressure on prices, especially with the entrance of generic manufacturers. However, differentiated products with added safety features or enhanced stability may sustain premium pricing.

4. Investment & R&D Outlook

Investments are steered toward developing prefilled, ready-to-infuse plastic containers, with a focus on patient safety and waste reduction. This innovation pipeline enhances market competitiveness and potential premium sales.

5. Market Risks & Opportunities

Risks include regulatory delays, adverse events associated with IV solutions (e.g., contamination, hypersensitivity reactions), and shifts in clinical preferences. Conversely, opportunities abound in personalized medicine approaches, with formulations tailored to specific patient needs.


Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Becton Dickinson (BD), and Fresenius Kabi. These companies focus on expanding their product portfolios, compliance capacity, and distribution networks.

Key Strategies Include:

  • Strategic acquisitions and alliances to enhance production capacity.
  • Launching novel formulations with improved stability.
  • Expanding distribution channels into emerging markets.
  • Emphasizing sustainability practices in packaging.

Regulatory Environment & Impact

Regulatory authorities emphasize stringent safety, sterility, and stability standards. Industry players must navigate approvals for ready-to-use plastic containers, often involving extensive clinical and stability testing. Non-compliance risks product rejections, recalls, and reputational damage.


Future Outlook and Trends

  • Automation & Digitalization: Use of serialization, track-and-trace systems, and IoT-enabled packaging enhances safety and supply chain transparency.

  • Sustainability Initiatives: Eco-friendly, biodegradable plastics could become industry standards, aligning with global environmental directives.

  • Personalized IV Therapy: Enhanced patient-specific formulations may open new revenue avenues, albeit requiring regulatory clarity.

  • Global Expansion: Growing healthcare expenditure in Asia-Pacific and Africa offers significant growth potential.


Key Takeaways

  • The global market for Dextrose 10% and Sodium Chloride 0.33% in plastic containers is poised for sustained growth, driven by healthcare infrastructure expansion, rising dehydration cases, and innovation in packaging.
  • Regulatory compliance, cost management, and supply chain resilience remain crucial for market participants.
  • Innovation in safety features, sustainability, and customized formulations will be pivotal in elevating competitive positioning.
  • Strategic investments in manufacturing and distribution can capitalize on emerging markets’ growth potential.
  • Partnerships and R&D are essential to develop differentiated, premium products aligned with evolving clinical needs.

FAQs

1. What factors are influencing the growth of IV hydration solutions?
Hospitalization rates, aging populations, chronic disease prevalence, and pandemic-related rehydration needs significantly drive demand.

2. How do regulatory requirements impact market entry?
Stringent safety, sterilization, and stability standards prolong approval timelines and increase compliance costs for manufacturers.

3. What are the main challenges faced by producers of Dextrose and Sodium Chloride solutions?
Pricing pressures, regulatory hurdles, supply chain disruptions, and competition from generics are primary challenges.

4. How will sustainability initiatives influence the packaging of IV solutions?
New biodegradable plastics and eco-friendly packaging practices will become essential to meet environmental regulations and customer preferences.

5. What growth opportunities exist in emerging markets?
Expanding healthcare infrastructure, rising disposable incomes, and increasing awareness present substantial expansion prospects.


References

[1] Market Research Future, "Intravenous Hydration Solutions Market Outlook," 2022.
[2] WHO, "Global Health Observatory Data," 2021.
[3] CDC, "Dehydration and Intravenous Therapy," 2022.

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