Last Updated: June 17, 2026

sodium acetate - Profile


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What are the generic sources for sodium acetate and what is the scope of patent protection?

Sodium acetate is the generic ingredient in one branded drug marketed by Amneal, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, Milla Pharms, and Somerset Theraps Llc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for sodium acetate
US Patents:0
Tradenames:1
Applicants:7
NDAs:7

US Patents and Regulatory Information for sodium acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469-003 Mar 2, 2026 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469-001 Aug 8, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 218469-002 Aug 8, 2025 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Extrovis SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 220274-001 Apr 17, 2026 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Extrovis SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 220274-002 Apr 17, 2026 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 206687-001 Oct 30, 2017 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma SODIUM ACETATE sodium acetate SOLUTION;INTRAVENOUS 216920-001 Mar 15, 2024 AP RX 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

Investment Scenario and Fundamentals Analysis for Sodium Acetate

Last updated: February 20, 2026

What is Sodium Acetate and Its Market Profile?

Sodium acetate is an organic salt with the formula CH₃COONa. It is used primarily in the pharmaceutical, food, and industrial sectors. In pharmaceuticals, it functions as a buffering agent, excipient, and in drug formulation, especially in infusion solutions and dialysis.

The global demand for sodium acetate is influenced by its use in manufacturing, medical applications, and food preservation. As of 2023, the market size for sodium acetate is estimated at approximately USD 200 million and projected to grow at a compound annual growth rate (CAGR) of about 4.5% through 2028 [1].

Key Supply and Demand Drivers

  • Pharmaceutical segment: Growing need for infusion solutions and dialysis applications.
  • Food industry: Use as a food additive (E262) for pH regulation.
  • Industrial use: In textile, leather, and printing industries.

Geographical Market Distribution

Region Market Share (2022) Growth Rate (2023-2028) Key Factors
Asia-Pacific 45% 5% Large pharmaceutical manufacturing, food sector expansion
Europe 25% 4% Stringent regulations, stable demand
North America 20% 4.2% Healthcare sector expansion, R&D investments
Rest of the World 10% 4.5% Emerging markets growth

Critical Factors Affecting Investment in Sodium Acetate

1. Manufacturing and Supply Dynamics

The supply chain relies on the availability of acetic acid (main raw material) and sodium compounds. Major producers include companies such as Eastman Chemical, Merck KGaA, and local Chinese manufacturers. Pricing is impacted by variations in raw material costs and environmental regulations influencing manufacturing processes.

2. Regulatory Environment

The compound’s approval status varies by region. In the EU, its use in pharmaceuticals and food is governed by EFSA approvals, with E262 classification. The US Food and Drug Administration (FDA) regulates its use in medical applications without significant hurdles, provided manufacturing standards meet Good Manufacturing Practice (GMP).

3. R&D and Innovation Opportunities

While sodium acetate is well-established, innovation appears in specialized medical formulations, controlled-release drug systems, and biotech applications. No significant patents restrict generic manufacturing, making the market accessible but also competitive.

4. Price Trends and Cost Considerations

Pricing varies based on purity grade, volume, and application-specific standards. Average unit prices have remained stable since 2018, with minor fluctuations driven by raw material costs. Bulk discounts are common at volume levels exceeding 10 tons.

5. Competitive Landscape

The market comprises a mix of producers, with a few regional leaders and numerous small suppliers. Market share concentration is moderate; no single entity dominates globally. Barriers to entry are relatively low, relying upon access to raw materials and compliance capabilities.

Investment Outlook

Positive Indicators

  • Rising demand due to expanded use in medical therapies.
  • Low market saturation in emerging economies.
  • Stable raw material costs when sourced from regional suppliers.

Risks

  • Regulatory changes removing or restricting use in specific sectors.
  • Raw material price volatility, especially acetic acid.
  • Competition from alternative buffering agents and excipients.

Strategic Recommendations

  • Investment in companies with integrated manufacturing and favorable regulatory standing.
  • Focus on regions with rapid pharmaceutical growth, especially Asia-Pacific.
  • Monitor raw material markets and supply chain stability.

Financial and Market Data Summary

Item Figures / Details
Estimated Market Size (2023) USD 200 million
Projected CAGR (2023-2028) 4.5%
Price Range (per ton, 2023) USD 2,000 – USD 3,000
Key Exporting Countries China, India, Germany
Regulatory Approvals Needed GMP, EFSA, FDA compliance

Key Takeaways

  • Sodium acetate has a stable, growing market driven by pharmaceutical and food applications.
  • Raw material costs and regulatory environments influence margins.
  • Market entry remains accessible, with regional players gaining traction.
  • Innovation focuses on niche medical formulations.
  • Investment opportunities exist in supply chain optimization and regional expansion.

FAQs

Q1: What distinguishes sodium acetate's market from other buffering agents?
It offers a balance of stability, low toxicity, and widespread regulatory acceptance, with low manufacturing barriers, making it a preferred choice in pharmaceutical formulations.

Q2: How are raw material costs affecting profitability?
Fluctuations in acetic acid prices directly impact sodium acetate production cost, but overall, stability in acetic acid markets limits significant margin pressure.

Q3: Which regions present the most promising growth opportunities?
Asia-Pacific, due to expanding pharmaceutical manufacturing and food processing capacity, offers the most significant growth potential.

Q4: Are there upcoming regulatory changes that could impact the market?
Any tightening of pharmaceutical excipient regulations or restrictions on food additive usage could affect demand. Currently, the regulatory landscape remains stable.

Q5: How does innovation influence the future market?
While current applications are mature, the development of specialized medical formulations and biotech uses could unlock new growth avenues.


References

[1] Market Research Future. (2023). Sodium Acetate Market Trends & Forecast to 2028.

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