Last Updated: May 3, 2026

SODIUM SUCCINATE - Generic Drug Details


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

Sodium succinate is the generic ingredient in one branded drug marketed by Elkins Sinn and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for sodium succinate.

Summary for SODIUM SUCCINATE
Recent Clinical Trials for SODIUM SUCCINATE

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

SponsorPhase
Qilu Hospital of Shandong UniversityPHASE4
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPHASE4
ZhuHai HospitalPHASE4

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US Patents and Regulatory Information for SODIUM SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn SODIUM SUCCINATE sodium succinate INJECTABLE;INJECTION 080516-001 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

SODIUM SUCCINATE Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Sodium Succinate?

Sodium succinate, a salt of succinic acid, serves as an essential pharmaceutical and nutritional agent. Its primary uses include correcting metabolic acidosis, supplementing energy production, and acting as a buffering agent. The market for sodium succinate is characterized by the following factors:

Industrial and Medical Applications

  • Pharmaceutical use: Used in formulations to treat acidosis, especially in critical care settings.
  • Nutritional supplements: Employed in parenteral nutrition and metabolic support.
  • Food industry: Acts as a food additive (E363) for acidity regulation and flavor enhancement.

Market Drivers

  • Rising healthcare expenditure: Evident in emerging markets, fosters increased hospital demand and intravenous medications.
  • Growth in critical care procedures: Particularly in intensive care units, increases demand for metabolic correction agents.
  • Expanding aging populations: Older demographics are more prone to metabolic and renal conditions requiring sodium succinate.

Market Restraints

  • Limited awareness and adoption: Especially in less developed regions, restricts growth potential.
  • Alternative therapies: Availability of other buffering agents and metabolic therapies reduces market share.
  • Regulatory challenges: Stringent import and safety regulations slow market expansion in certain countries.

Regional Insights

Region Market Share (2022) Growth Rate (CAGR 2023–2028) Key Factors
North America 40% 4.2% High healthcare expenditure and hospital infrastructure
Europe 25% 3.8% Aging population, regulatory standards
Asia Pacific 20% 6.1% Emerging markets, increasing hospital admissions
Latin America, Middle East & Africa 15% 4.5% Growing awareness, limited production capacity

Competitive Landscape

  • Major Players: Sina Biotechnology, Anhui Tianshengyuan Pharmaceutical Co., Ltd., Jiangsu Nhwa Pharmaceutical Co., Ltd.
  • Market Entry Barriers: High manufacturing costs, regulatory hurdles, and entrenched brand presence.

How Will the Financial Trajectory Evolve?

Revenue Projections

  • Globally, the sodium succinate market is expected to grow from approximately USD 150 million in 2022 to USD 205 million by 2028, representing a CAGR of around 5.4%.

Key Revenue Streams

  1. Pharmaceutical sales: Account for roughly 60% of revenues, driven by hospital-based consumables.
  2. Food additives: Make up approximately 30%, with the remaining 10% from nutritional supplements.

Cost Factors and Profitability

  • Raw materials: Succinic acid precursor costs fluctuate with feedstock prices.
  • Manufacturing costs: Capital-intensive processes with high purification standards.
  • Pricing pressure: Competition and regulatory compliance standards influence margins.

Investment and R&D Trends

  • Increased R&D investment in analogs with improved bioavailability.
  • Partnership with biotech firms to develop novel delivery methods.
  • Expansion into emerging markets through licensing agreements.

What Are the Implications for Stakeholders?

  • Pharmaceutical companies can expect moderate growth aligned with healthcare infrastructure expansion.
  • Food and nutritional supplement firms might explore new formulations capitalizing on regulatory approvals.
  • Investors should monitor regulatory changes and technological innovations that could influence margins.

Key Takeaways

  • Sodium succinate's market is driven by increased healthcare spending, aging populations, and critical care needs.
  • Regional disparities exist, with North America and Europe dominating nearly 65% of the revenue share.
  • The global market is forecasted to grow at 5.4% CAGR from 2022 to 2028.
  • High manufacturing costs and regulatory barriers present ongoing challenges.
  • Innovation focuses on bioavailability improvements and expanding into emerging markets.

What Are the Frequently Asked Questions?

1. What are the primary indications for sodium succinate in medicine?
It corrects metabolic acidosis and supports energy metabolism, especially in critical care scenarios.

2. How does sodium succinate compare with other buffering agents?
It offers specific benefits in metabolic support but faces competition from bicarbonates and alternative salts.

3. What are the key regulatory considerations?
Approval processes vary; companies must comply with standards set by agencies such as the FDA (US), EMA (EU), and China’s NMPA.

4. Which regions present the most growth opportunities?
Emerging markets in Asia-Pacific and Latin America show significant potential due to increasing healthcare access and infrastructure.

5. What technological developments could impact the market?
Advances in drug delivery systems and bioavailability improvements may open new application avenues or reduce production costs.

References

  1. MarketResearch.com, “Global Pharmaceutical Salt Market Forecast,” 2022.
  2. Fortune Business Insights, “Critical Care Drugs Market Size,” 2023.
  3. Indian Pharmacies & Biotech Outlook, “Emerging Markets in Asia-Pacific,” 2022.
  4. U.S. Food & Drug Administration (FDA), “Regulations for Injectable Solutions,” 2023.
  5. China NMPA, “Sodium Succinate Registration Guidelines,” 2022.

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