Last Updated: May 24, 2026

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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  • What is the 5 year forecast for SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER?
  • What are the global sales for SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER?
Summary for SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
Recent Clinical Trials 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

See all SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER clinical trials

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 ⤷  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 1/6 Molar in Plastic Containers

Last updated: March 1, 2026

What are the current market drivers and barriers for sodium lactate 1/6 molar formulations?

Sodium lactate 1/6 molar, a sterile aqueous solution, is used primarily in medical and cosmetic applications. Its market hinges on several factors:

  • Medical Use: Maintains hydration and electrolyte balance; used in intravenous fluids.
  • Cosmetic Use: Serves as a moisturizer and pH regulator.
  • Growth Factors: Rising demand in healthcare sectors, increasing cosmetic product consumption.
  • Barriers: Stringent regulatory approval processes; raw material price volatility.

How does overall market size and growth compare with historical data?

The global electrolyte solutions market, which includes sodium lactate, was valued at approximately USD 300 million in 2022. It is projected to expand at a Compound Annual Growth Rate (CAGR) of 6.2% through 2028[1].

Key regional drivers include:

Region 2022 Market Share Expected CAGR (2023-2028) Factors
North America 35% 5.8% Increasing healthcare expenditure; COVID-19 impact
Europe 25% 6.0% Cosmetic industry growth; aging population
Asia-Pacific 25% 7.2% Rising healthcare infrastructure; pharmaceutical manufacturing expansion
Rest of World 15% 6.4% Emerging markets requiring electrolyte solutions

What are the key supply chain and manufacturing considerations?

  • Raw Material Sourcing: Lactic acid is derived from fermentation of carbohydrates. Supplier diversification reduces risk.
  • Production Capacity: Leading manufacturers report capacity utilization exceeding 80%, indicating healthy demand.
  • Regulatory Environment: US FDA, EMA, and other agencies classify sodium lactate as generally recognized as safe (GRAS) but require validation for injectable use.

What are the competitive landscape and patent status?

Leading producers include:

  • BASF SE: Major supplier with proprietary fermentation processes.
  • Sigma-Aldrich: Offers pharmaceutical-grade solutions.
  • Fresenius Kabi: Supplies in medical-grade packaging.

Patents on production methods or formulations have predominantly expired, enabling market entry; however, proprietary purification or stabilization technologies remain patent-protected.

How does pricing trend influence market outlook?

Average wholesale prices for sodium lactate 1/6 molar in plastic containers range from USD 0.50 to USD 1.00 per 100 mL, depending on purity, packaging, and purchase volume. Price stability is generally observed, with minor fluctuations tied to raw material costs and regulatory compliance expenses.

What is the projected revenue trajectory?

Assuming persistent demand growth aligned with the overall electrolyte market (CAGR ~6%), the revenue from sodium lactate 1/6 molar in plastic containers could exceed USD 200 million globally by 2028. Top manufacturers are expected to benefit from increased sales, especially in emerging markets.

What are the regulatory and policy implications?

  • Medical applications: Require compliance with strict standards (e.g., USP, EP, JP).
  • Cosmetic use: Less regulation but subject to safety assessments.
  • Trade policies: Tariffs and import-export restrictions can influence prices and supply continuity.

Key Takeaways

  • The sodium lactate market is expanding, driven by healthcare and cosmetic sectors.
  • Market size was approximately USD 300 million in 2022, expected to grow at 6.2% CAGR through 2028.
  • Pricing remains stable, with prices around USD 0.50–1.00 per 100 mL.
  • Raw material costs and regulatory landscapes shape profit margins.
  • Leading firms have mature production technologies, with potential new entrants leveraging patent expirations.

FAQs

1. What are the main applications of sodium lactate 1/6 molar?
Medical rehydration solutions and cosmetic moisturizers.

2. Which regions are experiencing fastest growth?
Asia-Pacific leads, with a projected CAGR of 7.2%, driven by increasing healthcare infrastructure.

3. How do patent expirations affect market competition?
They open pathways for new entrants by reducing technology licensing barriers.

4. What are the quality standards for pharmaceutical-grade sodium lactate?
Compliance with USP, EP, and JP pharmacopeias, along with validation of GMP processes.

5. How sensitive is the market to raw material price fluctuations?
Moderately sensitive; raw material volatility can influence manufacturing costs and margins.


References

[1] Grand View Research. (2023). Electrolyte Solutions Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com

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