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Last Updated: December 17, 2025

SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER Drug Patent Profile


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When do Sodium Lactate 1/6 Molar In Plastic Container patents expire, and when can generic versions of Sodium Lactate 1/6 Molar In Plastic Container launch?

Sodium Lactate 1/6 Molar In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in SODIUM LACTATE 1/6 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 1/6 MOLAR IN PLASTIC CONTAINER
Drug patent expirations by year for SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
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SponsorPhase
University of California, Los AngelesPHASE2
Fundacin Cardioinfantil Instituto de CardiologaPHASE4
University of PittsburghPHASE4

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US Patents and Regulatory Information for SODIUM LACTATE 1/6 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 1/6 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 020004-001 Apr 21, 1992 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 1/6 Molar in Plastic Container

Last updated: July 28, 2025


Introduction

Sodium lactate, particularly in a 1/6 molar concentration packaged in plastic containers, occupies a significant niche within the pharmaceutical, cosmetic, and food industries. Its properties as a hygroscopic, isotonic solution make it an indispensable ingredient across diverse sectors. Understanding market dynamics and projecting financial trajectories require a comprehensive analysis of industry trends, regulatory landscape, competitive positioning, and technological advancements.


Market Overview

Sodium Lactate Market Context
Sodium lactate, a sodium salt of lactic acid, is chiefly used for hydration, electrolyte balance, skin conditioning, and as a buffering agent. The global market for sodium lactate was valued around USD 150 million in 2021, with an expected Compound Annual Growth Rate (CAGR) of approximately 4% from 2022 to 2028, driven by expanding applications in healthcare, personal care, and food industries (2).

Size and Enrollment of Key Segments
Pharmaceutical applications constitute roughly 50% of the sodium lactate market, with increasing demand from intravenous (IV) hydration solutions. The food industry accounts for nearly 30%, improving due to rising demand for natural preservatives. The cosmetics segment has experienced rapid growth, attributed to consumer preferences for bio-compatible ingredients.


Driving Forces in Market Dynamics

1. Clinical and Healthcare Expansion
Growth in IV therapy, especially amid aging populations and rising chronic disease prevalence, amplifies demand for sterile, isotonic solutions like sodium lactate. The COVID-19 pandemic further accelerated this trend, emphasizing electrolyte solutions in hospital settings (3).

2. Regulatory Environment
Stringent quality standards imposed by agencies such as the FDA (USA), EMA (Europe), and WHO influence supply chain integrity and production costs. The acceptance of sodium lactate as GRAS (Generally Recognized As Safe) facilitates its use in food and topical applications, broadening market scope.

3. Technological Innovations
Advances in manufacturing processes—such as aseptic filtration, improved sterilization, and container technology—enhance purity and shelf-life. Plastic container innovations (e.g., PET, HDPE) improve stability, facilitate transport, and reduce costs, bolstering supply chain resilience.

4. Competitive Landscape
Domination by key global producers such as Merck, Avantor, and Balkis Chemical Co. characterizes the mature segment. Smaller entrants focus on niche formulations or region-specific markets to gain market share.

5. Sustainability and Environmental Considerations
The shift towards eco-friendly packaging (bioplastics, recyclable plastics) is influencing material selection and manufacturing practices, adding both constraints and opportunities for market players.


Financial Trajectory Analysis

Revenue Growth Projections
Based on current market growth rates and expanding applications, revenues for sodium lactate 1/6 molar in plastic containers are projected to increase at a CAGR of approximately 4% over the next 5 years. The segment's growth is bolstered by increased demand for high-quality, sterile, ready-to-use solutions in hospitals and cleanroom environments.

Pricing Trends
Prices for sodium lactate solutions are relatively stable long-term, with fluctuations due to raw material costs (notably lactic acid and sodium hydroxide), regulatory compliance costs, and packaging innovations. The typical unit price for a 1/6 molar solution in a standard 500 mL plastic container ranges between USD 1.50 to USD 2.50, depending on purity and supplier.

Cost Structure and Margins
Manufacturing costs are influenced by:

  • Raw material procurement (lactic acid, sodium hydroxide)
  • Sterilization and quality assurance
  • Packaging and labeling (plastic containers)
  • Compliance and validation procedures

Gross margins typically range from 25% to 35%, with scope for improvement via process optimization and economies of scale.

Market Entry and Investment Opportunities
The growing demand offers avenues for new entrants with innovative container types, sourcing efficiencies, or geographic focus. Investors should evaluate supply chain stability, raw material availability, and regulatory compliance as prerequisites for favorable returns.


Regional and Sectoral Trends

North America and Europe
Dominant markets with high adoption rates due to established healthcare systems and stringent quality standards. The U.S. accounts for approximately 40% of regional sales.

Asia-Pacific
Emerging as a high-growth region, driven by expanding healthcare infrastructure, increasing demand for pharmaceutical solutions, and cost advantages. India and China are key manufacturing hubs.

Healthcare Sector
Continued reliance on electrolyte solutions in IV therapy sustains growth. The trend towards home healthcare may influence packaging formats and logistics.

Food & Personal Care sectors
Increasing consumer demand for natural, preservative-free products promotes sodium lactate use, contributing to diversified revenue streams.


Market Challenges and Risks

  • Raw Material Price Volatility: Fluctuations in lactic acid and sodium hydroxide impact costs.
  • Regulatory Hurdles: Variability in international standards can cause delays or added expenses.
  • Environmental Regulations: Stricter laws on plastic use and waste management may force investments in sustainable packaging.
  • Market Saturation: Maturation of core markets might slow growth, necessitating innovation.

Future Outlook

The trajectory of sodium lactate 1/6 molar in plastic containers hinges on healthcare modernization, sustainability initiatives, and technological progress. The integration of renewable raw materials and eco-friendly packaging is anticipated to influence market positionings. Continued investments in manufacturing efficiencies and expansion into emerging markets will likely be essential for sustaining growth.


Key Takeaways

  • The global sodium lactate market is projected to grow at approximately 4% CAGR through 2028, driven by healthcare, food, and cosmetic applications.
  • Demand for sterile, high-quality solutions in clinical settings sustains steady revenue growth, supporting a resilient financial outlook.
  • Raw material costs and environmental regulations are primary risks that could affect profit margins and pricing strategies.
  • Innovation in container technology and eco-friendly packaging can differentiate market players and unlock new opportunities.
  • Emerging markets in Asia-Pacific present high-growth prospects, with infrastructure development and increasing healthcare coverage acting as catalysts.

FAQs

1. What factors influence the pricing of sodium lactate solutions?
Primarily raw material costs, manufacturing efficiencies, regulatory compliance expenses, and packaging innovations influence pricing. Stable supply chains and economies of scale help maintain competitive prices.

2. How does regulatory compliance impact market entry?
Regulatory approval processes require adherence to safety, purity, and quality standards that can delay market entry and increase costs, especially in highly regulated regions like the US and EU.

3. What are the environmental considerations associated with plastic containers?
Environmental concerns around plastic waste lead to regulatory restrictions and consumer demands for sustainable packaging, prompting innovation in biodegradable or recyclable plastics.

4. Which regions offer the most growth potential for sodium lactate in the upcoming years?
The Asia-Pacific region is poised for significant growth due to expanding healthcare infrastructure, increasing industrialization, and cost advantages over Western markets.

5. How is technological innovation shaping the manufacturing of sodium lactate solutions?
Advances in sterilization, purification, and container materials enhance product safety, shelf-life, and environmental sustainability, providing competitive advantages.


References

[1] MarketWatch, "Global Sodium Lactate Market Size," 2022.
[2] Grand View Research, "Sodium Lactate Market Trends & Forecast," 2022.
[3] Allied Market Research, "Impact of COVID-19 on Electrolyte Solutions," 2021.

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