Last Updated: May 24, 2026

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
Recent Clinical Trials for SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

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

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER sodium lactate INJECTABLE;INJECTION 018249-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Molar in Plastic Container

Last updated: February 14, 2026

Market Overview

Sodium lactate, a saline solution used in medical, cosmetic, and food industries, has experienced stable demand driven by hospital applications, cosmetic formulations, and food preservation. The 0.167 molar concentration in plastic containers is specific to sterile, ready-to-use formulations for medical reconstitution, wound care, and hydration therapy.

Supply Chain and Production

Multiple manufacturers produce sodium lactate, often sourcing from regional chemical plants or integrating in-house synthesis. Major producers include BASF, SQM, and regional firms in Asia, Europe, and North America. Production costs vary based on raw material prices (lactic acid, sodium carbonate), energy costs, and regulatory compliance.

Pricing Trends

Pricing for sodium lactate solutions ranges from $0.50 to $2 per 100 mL, depending on purity, concentration, and packaging. The 0.167 molar solution in plastic containers typically commands a premium for sterility and convenience.

Market Drivers

  • Healthcare Demand: Increased use in intravenous fluids, wound care, and hydration for outpatient and inpatient care. Aging populations and chronic disease management boost demand.

  • Industrial Applications: Usage in cosmetics as a humectant and pH regulator. Food industry uses as a preservative and pH stabilizer.

  • Regulatory Environment: Stringent quality standards (e.g., USP, EP, FDA regulations) influence manufacturing and labeling, affecting entry barriers.

Market Challenges

  • Raw Material Costs: Fluctuations in lactic acid and sodium carbonate prices impact profitability. Price volatility can be linked to commodity markets.

  • Regulatory Approvals: Compliance costs for quality assurance and documentation can delay product launches and increase operational expenses.

  • Competition: Price competition from generic and regional producers constrains margins, especially in highly commoditized segments.

Financial Trajectory

  • Market Size: The global sodium lactate market was valued at approximately $200 million in 2022. It is projected to grow at a CAGR of 4-6% through 2027, driven by healthcare and cosmetic sectors.

  • Revenue Projections: For a manufacturer with a focus on volume sales of sodium lactate 0.167 molar in plastic containers, revenue could reach $35-45 million annually by 2027, assuming a compound annual growth rate (CAGR) of 5%. Larger pharmaceutical companies and regional producers with established distribution channels will capture significant market share.

  • Profit Margins: Margins vary between 15-30%, influenced by raw material costs, scale, and regulatory compliance. Cost control and supply chain efficiencies are critical to maintaining profitability.

  • Investment Outlook: New entrants face high initial regulatory costs and capacity investments. Mergers and acquisitions are common to expand manufacturing footprint and access new markets.

Competitive Landscape

Company Estimated Market Share Key Strengths
BASF 30% Diversified product portfolio, global reach
SQM 20% Strong Asian presence, cost-efficient production
Regional Firms 15-20% Price competitiveness, localized distribution
Others 30-35% Niche players, emerging markets

Minor players focus on niche segments or regional markets, often competing on price and supply reliability.

Regulatory and Market Entry Considerations

Regulatory pathways for sodium lactate solutions require compliance with pharmacopoeia standards, especially for injectable or wound care products. Certification costs and timeframes influence market entry strategies.

Strategic Opportunities

  • Product Differentiation: Packaging innovations, such as pre-sterilized, ready-to-use plastic containers, capture market segments seeking convenience.

  • Regional Expansion: Southeast Asia, Latin America, and Eastern Europe represent growth opportunities due to expanding healthcare infrastructure.

  • Vertical Integration: Controlling raw material sourcing can stabilize costs amid raw material price fluctuation.

Key Takeaways

Sodium lactate 0.167 molar in plastic containers is a mature, segmentally stable product with growth propelled by healthcare, cosmetics, and food industries. Profitability hinges on supply chain efficiency, regulatory compliance, and competitive cost management. Market expansion will primarily occur through regional growth and product differentiation strategies.

FAQs

  1. What factors influence the price of sodium lactate solutions? Raw material costs, purity standards, packaging quality, and supply chain dynamics.

  2. Which sectors are primary consumers of sodium lactate 0.167 molar solutions? Healthcare (intravenous fluids, wound care), cosmetics (moisturizers, pH adjusters), and food preservation.

  3. What are regulatory hurdles for market entry? Compliance with pharmacopoeial standards (USP, EP), quality assurance protocols, and manufacturing licenses.

  4. How does regional regulation affect market growth? Regions with stringent regulations may restrict entry or increase compliance costs, affecting profit margins and speed-to-market.

  5. What is the outlook for new entrants? High initial capital, regulatory hurdles, and established competition act as barriers; success depends on niche targeting or regional focus.

References

[1] Market Research Future, "Sodium Lactate Market," 2022.

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