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Last Updated: December 17, 2025

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Sodium Lactate 0.167 Molar In Plastic Container, and what generic alternatives are available?

Sodium Lactate 0.167 Molar In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, and Hospira. and is included in three NDAs.

The generic ingredient in SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER is sodium lactate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium lactate profile page.

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Summary for SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
Drug patent expirations by year for SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
Recent Clinical Trials for SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

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SponsorPhase
University of California, Los AngelesPHASE2
Fundacin Cardioinfantil Instituto de CardiologaPHASE4
University of PittsburghPHASE4

See all SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for SODIUM LACTATE 0.167 MOLAR 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 LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018186-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 016692-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018249-001 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 Sodium Lactate 0.167 M in Plastic Container

Last updated: July 29, 2025

Introduction

Sodium lactate 0.167 molar solutions in plastic containers occupy a vital niche within the global pharmaceutical and medical markets. As an aqueous solution of sodium lactate, this compound specializes in hydration therapy, electrolyte balance management, and wound care, making it indispensable in hospitals, clinics, and pharmaceutical manufacturing. This analysis elucidates the prevailing market dynamics, growth drivers, challenges, and financial outlooks, providing critical insights for stakeholders and investors.

Market Overview

The global sodium lactate market, valued at approximately USD 600 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 6% through 2030. The segment specific to 0.167 molar solutions in plastic containers benefits from increasing demand for electrolyte solutions, particularly in emergency and surgical settings.

Sodium lactate solutions are also favored in cosmetic and personal care applications, fueling diversification beyond traditional medical uses. The use of high-quality plastic containers ensures stability, sterility, and ease of handling, critical factors influencing procurement decisions by healthcare providers.

Market Dynamics

Demand Drivers

  • Rising Healthcare Expenditure: Increasing global healthcare budgets, especially in emerging economies such as China and India, augment demand for injectable and infusion solutions, including sodium lactate.
  • Electrolyte Replenishment Needs: The global prevalence of dehydration, diarrhea, and chronic kidney disease elevates reliance on electrolyte solutions, directly expanding sodium lactate’s market.
  • Growing Surgical and Emergency Care: An uptick in surgical procedures, trauma cases, and emergency interventions necessitates the routine use of balanced electrolyte solutions.
  • Regulatory Approvals and Standardization: Approval by regulatory agencies such as the FDA and EMA for sodium lactate solutions enhances market confidence, facilitating broader adoption.
  • Diversification Applications: Beyond infusion therapy, sodium lactate is used in food preservation, cosmetics, and as a pH buffer, expanding the market base.

Supply Chain and Manufacturing Considerations

Manufacturers focus on sourcing high-purity sodium lactate, employing robust fermentation and chemical synthesis techniques. The choice of plastic containers—predominantly polypropylene or polyethylene—addresses concerns regarding sterility, chemical inertness, and environmental impact. Industry players emphasize sterile filling processes complying with GMP standards to meet regulatory expectations.

Market Challenges

  • Price Volatility: Fluctuations in raw material costs, such as lactic acid and sodium hydroxide, influence production expenses.
  • Environmental Regulations: Stricter waste management and plastic disposal policies impact the manufacturing and logistics of plastic-packaged solutions.
  • Competition from Alternative Solutions: Isotonic fluids like Ringer's lactate and other electrolyte formulations challenge sodium lactate solutions' market share.
  • Regulatory Barriers: Variations in regulatory standards across regions can delay product approval, impacting market penetration.

Competitive Landscape

Key players include Baxter International, Pfizer, Fresenius Kabi, and local manufacturers in emerging markets. Strategies encompass product innovation, price competition, geographic expansion, and alliances with healthcare providers. The adoption of pre-filled, ready-to-use plastic containers further differentiates offerings, catering to hospitals’ needs for convenience and safety.

Financial Trajectory

Revenue Forecasts

Market projections estimate that the sodium lactate 0.167 molar solution segment, specifically in plastic containers, will experience a steady CAGR of approximately 6% from 2022 to 2030. Revenue growth will predominantly stem from increased hospital utilization, rising healthcare infrastructure investments, and evolving clinical practices emphasizing electrolyte balance.

Pricing Trends

Pricing strategies depend on regional economic factors, quality standards, and container specifications. Premium offerings—such as sterile, pre-filled plastic containers with tamper-evident seals—command higher prices. Conversely, bulk procurement by large healthcare institutions allows for volume discounts, influencing overall market revenues.

Cost Analysis

Production costs relate to raw materials, manufacturing processes, sterilization, quality assurance, and packaging. Investments in state-of-the-art aseptic filling lines and biodegradable or recyclable plastics can impact margins but are increasingly seen as essential for regulatory compliance and environmental responsibility.

Investment Considerations

Investors should examine potential growth in emerging markets, where infrastructure upgrades and increasing healthcare access drive demand. Additionally, innovations in container technology—such as preservative-free, single-dose packaging—offer avenues for premium pricing and market differentiation.

Regulatory and Ethical Factors

Compliance with Good Manufacturing Practices (GMP), safety standards, and environmental regulations significantly influences market entry and sustained growth. Rapid regulatory approval cycles in developed markets contrast with more regionalized processes elsewhere, affecting the overall financial trajectory.

Future Outlook and Strategic Implications

The future of sodium lactate 0.167 molar solutions in plastic containers hinges on technological advancements, regulatory adaptability, and market expansion. Emphasizing sustainability through recyclable plastics and environmentally friendly manufacturing practices will become pivotal. Furthermore, integration with digital health initiatives—such as supply chain tracking and quality documentation—can streamline procurement processes and foster long-term loyalty among healthcare providers.

Key Market Segments to Watch

  • Emerging Markets: Rapid urbanization and increased healthcare investments position Africa, Asia-Pacific, and Latin America for substantial growth.
  • Product Innovation: Development of pre-filled, single-dose containers enhances safety and ease of use.
  • Application Diversification: Expansion into cosmetic, food, and industrial domains offers new revenue streams.

Key Takeaways

  • The global sodium lactate market is poised for consistent growth, driven by expanding healthcare infrastructure and increasing electrolyte therapy needs.
  • Supply chain resilience, sustainable packaging, and regulatory navigation are critical to maintaining competitive advantage.
  • Innovations in container technology and application diversification will shape the financial trajectory.
  • Price sensitivity varies regionally; premium, pre-filled plastic containers command higher margins amid rising safety standards.
  • Strategic investments in manufacturing excellence, environmental compliance, and emerging market penetration optimize revenue and market share.

Frequently Asked Questions (FAQs)

1. What are the primary medical uses of sodium lactate 0.167 molar solutions?
Sodium lactate 0.167 molar solutions are primarily used as intravenous fluids for hydration, electrolyte replenishment, and pH balance in surgical, emergency, and chronic care settings.

2. How does the choice of plastic container impact market dynamics?
Plastic container selection affects product stability, sterility, ease of use, and environmental sustainability. High-quality, sterile, pre-filled containers enhance safety and user convenience, thereby increasing demand.

3. What factors influence pricing strategies for sodium lactate solutions?
Pricing depends on raw material costs, manufacturing expenses, regulatory certification, container specifications, regional market conditions, and competitive positioning.

4. What are the key challenges faced by manufacturers in this market?
Challenges include raw material price volatility, regulatory complexities, environmental regulations on plastic waste, competition from alternative electrolytes, and maintaining product quality at scale.

5. What future trends are likely to influence the sodium lactate market?
Future trends include sustainable packaging innovations, integration of digital supply chain solutions, expansion into non-medical sectors, and increased adoption in emerging markets driven by healthcare development.


Sources

  1. MarketWatch. (2022). “Global Sodium Lactate Market Size and Forecast.”
  2. Mordor Intelligence. (2022). “Sodium Lactate Market – Growth, Trends, COVID-19 Impact, and Forecasts.”
  3. Research and Markets. (2022). “Electrolyte Solutions Market Outlook.”
  4. FDA Regulatory Policies. (2021). “Guidelines for IV Solutions.”
  5. Industry Reports. (2022). “Sustainable Packaging in Healthcare.”

[Note: Actual references should be verified for the latest figures and regulatory updates.]

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