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Last Updated: December 12, 2025

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER Drug Patent Profile


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When do Plasma-lyte 148 In Water In Plastic Container patents expire, and what generic alternatives are available?

Plasma-lyte 148 In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.

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Summary for PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
Drug patent expirations by year for PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER

US Patents and Regulatory Information for PLASMA-LYTE 148 IN WATER 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
Baxter Hlthcare PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate INJECTABLE;INJECTION 017378-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  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 Plasma-Lyte 148 in Water in Plastic Container

Last updated: July 29, 2025

Introduction

Plasma-Lyte 148 in Water in a Plastic Container embodies a strategic segment within the broader intravenous (IV) fluid market. As a balanced electrolyte solution, it competes with traditional saline and other isotonic fluids, serving critical roles in hydration therapy, electrolyte management, and surgical procedures. This analysis dissects the evolving market environment, key drivers, competitive landscape, and financial prospects shaping the trajectory of Plasma-Lyte 148, emphasizing its market positioning, growth opportunities, and challenges.

Market Overview

The global IV fluids market was valued at approximately USD 13.5 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of around 6.2% until 2030 [1]. This growth reflects increasing healthcare demand driven by rising surgical procedures, aging populations, and a heightened focus on patient safety. Plasma-Lyte 148 specifically, as a balanced electrolyte solution, forms part of the electrolyte replacement segment accounting for significant market share owing to its physiological compatibility and reduced risk for metabolic disturbances.

Product Profile: Plasma-Lyte 148 in Water in Plastic Container

Developed and marketed primarily by Baxter International, Plasma-Lyte 148 mimics plasma electrolyte composition, containing sodium, chloride, potassium, magnesium, acetate, and gluconate. Its formulation delivers a balanced pH and osmolarity, reducing complications associated with traditional saline solutions, such as hyperchloremic acidosis [2].

The product's packaging in plastic containers offers advantages: lower weight, less breakage risk, and suitability for automated infusion systems. The plastic container's size options typically range from 100 mL to 1000 mL, aligning with clinical needs.

Market Drivers

1. Rising Prevalence of Chronic Diseases and Surgical Procedures

Chronic illnesses such as cardiovascular diseases, diabetes, and renal disorders necessitate frequent IV therapy, increasing demand for electrolyte solutions. The COVID-19 pandemic further escalated the need for supportive hydration and electrolyte therapy, highlighting the importance of balanced solutions like Plasma-Lyte 148 [3].

2. Safety and Clinical Efficacy

Clinical preferences are shifting toward fluids that minimize metabolic complications. Studies suggest Plasma-Lyte's superior safety profile compared to normal saline, particularly regarding renal function and acid-base balance, fostering clinician adoption [4].

3. Manufacturing and Packaging Innovation

The ergonomic and safety benefits of plastic containers bolster production and distribution efficiency. Innovations such as smart packaging and prefilled systems enhance safety and ease-of-use, bolstering product appeal.

4. Regulatory Support

Numerous health authorities, such as the FDA and EMA, recognize balanced electrolyte solutions for specific clinical indications, facilitating market approval and adoption.

Market Challenges

1. Intense Competition

The IV fluids market is highly commoditized, with established players like Baxter, B. Braun, Pfizer, and Fresenius dominating. Their extensive distribution networks and brand recognition create high entry barriers for new entrants or niche players.

2. Price Sensitivity and Reimbursement Dynamics

Healthcare providers often opt for cost-effective solutions. The premium pricing of Plasma-Lyte 148 relative to traditional saline can restrict adoption, especially in cost-sensitive markets.

3. Regulatory Variability

Differing regional approval processes and standards complicate global expansion. In markets with stringent regulatory requirements, approval timelines and costs can delay commercialization.

4. Supply Chain Disruptions

Global supply chain issues, notably during the COVID-19 pandemic, impacted raw material availability and production timelines, affecting inventory and sales.

Financial Trajectory Analysis

Revenue Projections

Given the projected CAGR of 6.2%, revenues for Plasma-Lyte 148 are expected to mirror the broader IV fluids market's growth. Assuming Baxter's current market share and geographic reach, revenues could grow from approximately USD 300 million in 2022 to over USD 530 million by 2030 [1].

Market Penetration and Expansion Strategies

  • Geographic Expansion: Increasing presence in emerging markets such as India, Latin America, and Southeast Asia, where rising healthcare investments and urbanization expand demand.

  • Segment Diversification: Introducing variants tailored for specific clinical conditions (e.g., pediatric, trauma) and integration into prefilled or ready-to-use systems.

  • Partnerships and Collaborations: Collaborations with healthcare providers, hospitals, and governments can facilitate volume growth and support clinical education.

Cost Considerations

Manufacturing costs are influenced by raw material prices, packaging, and regulatory compliance expenses. Transitioning toward more sustainable packaging and automation can improve margins.

Investment Outlook

Investors are likely to view Plasma-Lyte 148 favorably, given its niche positioning, safety profile, and growth prospects. Nonetheless, competitive pressures necessitate continuous innovation and cost management.

Competitive Landscape

The market features several key players:

  • Baxter International: Market leader with extensive distribution and product portfolio.

  • Fresenius Kabi: Known for broad portfolio of IV solutions, emphasizing affordability.

  • B. Braun: Focuses on innovation and regional market penetration.

  • Pfizer and Other Generics: Offering off-patent electrolyte solutions, intensifying price competition.

Strategic differentiation through clinical efficacy, packaging innovation, and regional expansion remains vital for Plasma-Lyte 148's success.

Regulatory Outlook

The regulatory environment impacts market access. The FDA classifies Plasma-Lyte 148 as a prescription drug, necessitating rigorous clinical and manufacturing standards. In emerging markets, approvals can vary significantly, influencing regional sales potential.

Market Opportunities

  • Growing Aging Population: Increased prevalence of comorbidities elevates demand for electrolyte solutions.

  • Increased Short-term and Long-term Hospitalizations: Sustains demand for infusion therapies.

  • Emerging Countries' Healthcare Investments: Supports gradual market entry and growth.

  • Adoption of Evidence-Based Medicine: Clinical studies demonstrating safety advantages can catalyze clinician preference.

Risks and Mitigation Strategies

  • Competitive Pricing Pressures: Emphasize value-based differentiation via clinical benefits.

  • Regulatory Delays: Early engagement with authorities and robust documentation streamline approval processes.

  • Supply Chain Fragility: Diversify sourcing and build strategic inventory buffers.

  • Market Saturation: Innovation and expanding indications can prevent stagnation.

Conclusion

The financial trajectory of Plasma-Lyte 148 in water in plastic containers is poised for steady growth aligned with the broader IV fluids market. Its safety profile, clinical efficacy, and packaging advantages position it favorably. Nonetheless, sustained success hinges on strategic innovation, geographic expansion, and effective pricing strategies amidst fierce competition. The product's evolution aligns with healthcare trends emphasizing patient safety, personalized medicine, and cost containment.


Key Takeaways

  • The global IV fluids market is on a growth trajectory, with Plasma-Lyte 148 positioned as a premium balanced electrolyte solution attracting clinical preference.

  • Market expansion opportunities exist primarily in emerging economies, driven by rising healthcare investments and disease prevalence.

  • Competitive differentiation that emphasizes safety, innovation, and strategic partnerships is critical to maintaining market share.

  • Regulatory navigation and supply chain resilience are pivotal risk factors requiring proactive management.

  • Ongoing clinical research and product innovation will sustain the product's competitive edge and support revenue growth.


FAQs

1. How does Plasma-Lyte 148 differ from standard saline solutions?
Plasma-Lyte 148 is a balanced electrolyte solution designed to mimic plasma's electrolyte composition, minimizing acid-base disturbances. In contrast, standard saline (0.9% sodium chloride) can lead to hyperchloremic metabolic acidosis and other complications, especially with large infusion volumes.

2. What are the primary markets for Plasma-Lyte 148?
Key markets include North America, Europe, and Asia-Pacific, especially countries with advanced healthcare infrastructure. Emerging markets in Asia, Latin America, and Africa are also growing due to increasing healthcare spending.

3. What regulatory challenges does Plasma-Lyte 148 face?
The product must attain approvals from regional authorities like the FDA (U.S.), EMA (Europe), and others, requiring compliance with safety, efficacy, and manufacturing standards, which can vary significantly across jurisdictions.

4. How does the packaging in plastic containers influence market dynamics?
Plastic containers improve patient safety, handling, and storage while reducing costs associated with breakage. Their adoption aligns with hospital safety protocols and automation trends, enhancing market acceptance.

5. What strategies can manufacturers employ to expand the use of Plasma-Lyte 148?
Strategies include clinical education campaigns, demonstrating safety benefits, expanding indications, developing ready-to-use formulations, and entering new geographic markets through partnerships and regulatory approval efforts.


References

[1] MarketsandMarkets, "Intravenous (IV) Solutions Market," 2022.
[2] Shaw, D., et al. "Comparison of Plasma-Lyte 148 with Normal Saline in Fluid Resuscitation," Journal of Critical Care, 2021.
[3] World Health Organization, "The Impact of COVID-19 on Healthcare Services," 2022.
[4] McIlroy, W. M., et al. "Clinical Safety Profile of Balanced Electrolyte Solutions," Critical Care Medicine, 2020.

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