Edetate calcium disodium - Generic Drug Details

What are the generic drug sources for edetate calcium disodium and what is the scope of freedom to operate?

Edetate calcium disodium is the generic ingredient in two branded drugs marketed by Bausch and Casper Pharma Llc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for edetate calcium disodium. One supplier is listed for this compound.

Summary for edetate calcium disodium

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	7,059
What excipients (inactive ingredients) are in edetate calcium disodium?	edetate calcium disodium excipients list
DailyMed Link:	edetate calcium disodium at DailyMed

Recent Clinical Trials for edetate calcium disodium

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

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
M.D. Anderson Cancer Center	Phase 1
National Cancer Institute (NCI)	Phase 1

See all edetate calcium disodium clinical trials

Pharmacology for edetate calcium disodium

Drug Class	Anti-coagulant Lead Chelator
Mechanism of Action	Calcium Chelating Activity Lead Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

US Patents and Regulatory Information for edetate calcium disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	CALCIUM DISODIUM VERSENATE	edetate calcium disodium	TABLET;ORAL	008922-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Casper Pharma Llc	EDETATE CALCIUM DISODIUM	edetate calcium disodium	INJECTABLE;INJECTION	216435-001	May 3, 2023		RX	No	Yes
Bausch	CALCIUM DISODIUM VERSENATE	edetate calcium disodium	INJECTABLE;INJECTION	008922-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Edetate Calcium Disodium

Last updated: July 28, 2025

Introduction

Edetate Calcium Disodium, commonly known as Calcium EDTA, is a chelating agent primarily utilized within medical, industrial, and environmental sectors. Its significance in pharmaceutical applications, particularly for heavy metal poisoning and certain diagnostic procedures, positions it as a specialty yet vital drug. The evolving landscape of chemical safety regulations, rising prevalence of heavy metal poisoning, and advancements in chelation therapy are shaping its market dynamics. This analysis explores the current market environment, competitive landscape, regulatory status, and future financial prospects of Edetate Calcium Disodium.

Market Overview

Edetate Calcium Disodium, registered under various trade names such as Calcium EDTA, has historically been used to treat heavy metal poisoning, including lead, mercury, and arsenic poisoning. Its relevance extends to applications like radiocontrast agent removal and industrial water treatment. The global demand correlates with increased exposure to heavy metals, industrialization, and healthcare needs related to poisoning management.

The pharmaceutical sector accounts for a significant share of its end-use, with the therapy often administered in hospitals and specialized clinics. Notably, regulations surrounding heavy metal safety and environmental policies influence manufacturing and utilization trends.

Market Drivers

Growing Incidence of Heavy Metal Poisoning

The rise in heavy metal exposure due to industrial pollution, contaminated water sources, and cosmetic products subjects populations to increased poisoning risks. According to the World Health Organization (WHO), lead poisoning remains a significant health concern globally, especially in developing regions. Consequently, demand for chelating agents like Calcium EDTA escalates.

Advancements in Chelation Therapy

Medical research continually refines chelation therapies, aiming for specificity, reduced toxicity, and improved efficacy. Edetate Calcium Disodium remains a first-line treatment for acute heavy metal toxicity, reinforcing its market position.

Regulatory and Environmental Policies

Implementation of stricter environmental standards has fueled demand for chelators in industrial water treatment and waste management, indirectly bolstering pharmaceutical applications.

Increased Awareness and Healthcare Infrastructure

Enhanced awareness of heavy metal poisoning and better healthcare infrastructure in emerging economies expand the market footprint for Calcium EDTA.

Market Challenges

Competition from Alternative Chelating Agents

Agents like Dimercaprol, DMSA, and DMPS offer alternative options, sometimes with improved safety profiles, posing competition.

Regulatory Constraints

Stringent regulations governing manufacturing processes, quality control, and quality standards (e.g., FDA, EMA) increase compliance costs, potentially impacting profitability.

Supply Chain Constraints

Limited raw material suppliers and geopolitical factors influence availability and price stability.

Regulatory Landscape

Calcium EDTA is generally classified as an over-the-counter or prescription drug depending on regional regulations. The U.S. Food and Drug Administration (FDA) Approves Edetate Calcium Disodium for specific indications, with manufacturing adhering to Good Manufacturing Practices (GMP).

In the European Union, the European Medicines Agency (EMA) regulates its usage, emphasizing safety and efficacy. Emerging markets often follow WHO guidelines, with local regulatory bodies imposing varying approval standards.

Financial Trajectory and Market Forecast

Historical Revenue and Market Size

The global chelation therapy market was valued at approximately USD 1.2 billion in 2021, with Calcium EDTA constituting a substantial proportion driven by lead poisoning cases (1). Its pharmaceutical segment has registered steady growth, propelled by the rising incidence of heavy metal toxicity.

Projection for the Next Decade

Analysts project a compound annual growth rate (CAGR) of around 5%–7% over the 2022–2030 period (2). Factors contributing to this trajectory include:

• Continued industrialization and environmental exposure
• Expanding healthcare infrastructure, especially in Asia-Pacific
• New therapeutic indications and formulations

Emerging Trends and Opportunities

• Innovations in Chelation Delivery: Development of targeted, less toxic formulations could enhance market appeal.
• Environmental Applications: Expansion into industrial waste remediation presents new revenue streams.
• Post-Pandemic Healthcare Focus: Increased attention to environmental health due to COVID-19-related pollution concerns may augment demand.

Competitive Landscape

Global production is concentrated among a handful of pharmaceutical firms and chemical manufacturers, with key players like Pfizer, Merck, and local manufacturers in emerging markets. Licensing agreements and regional expansions personalize the competitive strategy.

Conclusion and Outlook

The market for Edetate Calcium Disodium stands at a crossroads of increasing healthcare needs and regulatory vigilance. Its steady growth is underpinned by ongoing heavy metal poisoning cases and environmental remediation efforts. While competitive pressures and regulatory hurdles exist, innovation and expanding applications offer promising avenues.

The anticipated CAGR of approximately 6% suggests a resilient, albeit niche, pharmaceutical segment. Robust supply chain management, proactive regulatory compliance, and R&D investments will be critical for key stakeholders aiming to capitalize on this trajectory.

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Key Takeaways

• Rising global heavy metal poisoning incidences sustain demand for Edetate Calcium Disodium.
• Medical advancements and regulatory strictness influence market growth and product development.
• The chelation therapy market is projected to grow steadily, with calcium EDTA maintaining a prominent position.
• Supply chain vulnerabilities and competition necessitate strategic positioning, R&D, and diversification.
• The environmental application sector presents untapped growth potential, expanding revenues beyond traditional pharmaceutical use.

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FAQs

1. What is the primary medical indication for Edetate Calcium Disodium?
It is predominantly used to treat acute heavy metal poisoning, especially lead, mercury, and arsenic toxicity.

2. How does Edetate Calcium Disodium compare to other chelating agents?
While effective in treating heavy metal poisoning, Calcium EDTA may have a different safety profile and administration route compared to alternatives like DMSA, which is oral, or Dimercaprol, which can cause more side effects.

3. What are the main regulatory hurdles for Edetate Calcium Disodium?
Regulatory challenges include ensuring manufacturing quality, confirming safety and efficacy, and adhering to environmental standards, which vary by region.

4. How does environmental regulation impact the market for Calcium EDTA?
Environmental policies promoting pollutant control increase demand for chelating agents in industrial waste remediation, indirectly boosting pharmaceutical applications.

5. What future innovations could influence Edetate Calcium Disodium's market?
Development of targeted delivery methods, safer formulations, and expanded uses in environmental remediation are potential growth drivers.

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References

1. Research and Markets. (2021). Chelation Therapy Market Analysis.
2. Fortune Business Insights. (2022). Chelation Therapy Market Size, Share & Industry Analysis.

Note: All numerical data and forecasts are based on publicly available industry reports and market analyses as of 2023.