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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. Two suppliers are 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:	2
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	4
Patent Applications:	1,555
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	Phase 1
National Cancer Institute (NCI)	Phase 1
Mt. Sinai Medical Center, Miami	Phase 4

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	INJECTABLE;INJECTION	008922-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
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

Edetate calcium disodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Edetate Calcium Disodium

Overview of Edetate Calcium Disodium

Edetate calcium disodium, also known as calcium disodium versenate, is a metal ion chelator primarily used to treat severe lead poisoning. It is a polyvalent ion chelator that reduces blood concentrations and depot stores of lead from the body[2][5].

Market Size and Growth Outlook

The market for edetate calcium disodium is part of the broader specialty chemicals and pharmaceuticals industry. Here are some key points regarding its market dynamics:

• Global Market: The global market for edetate calcium disodium is expected to see fluctuations due to various economic and geopolitical factors. However, improvements in the economy and alleviation of supply chain concerns are projected to facilitate a rebound in demand, particularly in the latter half of 2024 and beyond[1].

• Regional Variations: The market is split across regions such as North America, Europe, Asia Pacific, Middle East, Africa, and LATAM/South and Central America. Each region has its own set of economic and social challenges, necessitating regional-specific strategies for market players[1].

Market Drivers

Several factors drive the growth of the edetate calcium disodium market:

• Increasing Need for Lead Poisoning Treatment: The primary driver is the ongoing need for effective treatments for lead poisoning, which remains a significant health concern in many parts of the world[2][5].

• Government Policies and Incentives: Government policies promoting the use of bio-chemicals and materials in the manufacturing sector have bolstered the growth of the industry. These policies often include incentives for companies to adopt cleaner and more sustainable practices[1].

• Technological Advancements: Investments in new technologies and efficient procurement and inventory management are crucial for sustaining growth in the face of challenging conditions. Companies are leveraging these capabilities to enhance their product portfolios and operational efficiency[1].

Market Challenges

Despite the drivers, the market faces several challenges:

• Economic Slowdown: The global economic slowdown and the impact of geopolitical tensions have significant effects on the supply chain and raw material costs. These factors contribute to subdued economic growth and delayed recovery in specific regions[1].

• Shifting Consumer Preferences: Changes in consumer preferences, particularly towards more sustainable and environmentally friendly products, pose a challenge for the industry. Companies must adapt their strategies to align with these growing environmental concerns[1].

• Regulatory Framework: Establishing a robust regulatory framework is crucial but challenging. Effective collaboration within the chemical industry and across the value chain is necessary to achieve consensus on initiatives that balance supply, demand, and financial factors[1].

Financial Trajectory

The financial trajectory of the edetate calcium disodium market is influenced by several key factors:

• Revenue Projections: The global market revenue for edetate calcium disodium is estimated based on market prices, production, supply, demand, and trade logistics across regions. Detailed market share statistics and shifts in demand for different types and applications are included in market research reports[1].

• Cost Management: Companies are prioritizing cost consciousness and operational efficiency due to uneven recovery across different end markets and geographies. This involves managing raw material costs, which can fluctuate significantly due to geopolitical tensions[1].

• Investment Strategies: Market players are directing investments towards acquiring new technologies, securing raw materials, and enhancing product portfolios. These strategies are aimed at sustaining growth amidst challenging economic conditions[1].

Competitive Landscape

The competitive landscape of the edetate calcium disodium market is analyzed using Porter's Five Forces:

• Threat of New Entrants: The market has moderate barriers to entry due to the need for significant capital investment and compliance with stringent regulatory requirements[1].

• Bargaining Power of Suppliers: Suppliers have considerable bargaining power due to the critical nature of raw materials and the impact of geopolitical tensions on supply chains[1].

• Bargaining Power of Buyers: Buyers have moderate bargaining power, influenced by the availability of substitutes and the specific needs for lead poisoning treatment[1].

• Intensity of Competitive Rivalry: The market experiences high competitive rivalry due to the presence of several established players and the need for continuous innovation and cost management[1].

• Threat of Substitutes: The threat of substitutes is moderate, with other chelating agents like succimer being used for different levels of lead poisoning. However, edetate calcium disodium remains a preferred option for severe cases[5].

Recent Developments and Trends

• Technological Innovations: Recent developments include advancements in manufacturing processes and the integration of new technologies to improve efficiency and reduce costs[1].

• Regulatory Changes: There is a growing emphasis on cleaner and sustainable practices, driven by government policies and consumer preferences. Companies are adapting to these changes by investing in more environmentally friendly production methods[1].

• Clinical Trials and Research: Ongoing clinical trials and research are focused on improving the efficacy and safety of edetate calcium disodium. For example, studies have explored its potential in reducing adverse cardiovascular outcomes, although these uses are not widely recommended due to potential side effects[5].

Key Takeaways

• The edetate calcium disodium market is expected to rebound in the latter half of 2024 driven by economic improvements and supply chain alleviations.
• Government policies and technological advancements are key drivers of market growth.
• The market faces challenges such as economic slowdown, shifting consumer preferences, and regulatory complexities.
• Effective cost management and operational efficiency are crucial for market players.
• The competitive landscape is characterized by moderate barriers to entry, significant supplier bargaining power, and high competitive rivalry.

FAQs

What is the primary use of edetate calcium disodium?

Edetate calcium disodium is primarily used to treat severe lead poisoning by reducing blood concentrations and depot stores of lead from the body[2][5].

How does edetate calcium disodium work?

Edetate calcium disodium works by chelating lead ions, which are then eliminated through urinary excretion. It displaces calcium ions to form a stable ring compound with the lead ions[5].

What are the key challenges facing the edetate calcium disodium market?

The market faces challenges such as economic slowdown, shifting consumer preferences towards sustainable products, and significant fluctuations in raw material costs due to geopolitical tensions[1].

How is the competitive landscape of the edetate calcium disodium market?

The market is characterized by moderate barriers to entry, significant supplier bargaining power, moderate buyer bargaining power, high competitive rivalry, and a moderate threat of substitutes[1].

What are the recent trends in the edetate calcium disodium market?

Recent trends include technological innovations, a growing emphasis on sustainable practices, and ongoing clinical trials to improve the efficacy and safety of the drug[1][5].

Sources

1. 2024 Disodium EDTA Market Outlook Report: Research and Markets.
2. Edetate calcium disodium: DrugBank.
3. Global Calcium Disodium Versenate (Edetate Calcium Disodium) Market Research Report 2024: Market Research Reports.
4. Global Calcium Disodium Edetate Market Size, Trends and Projections: Market Research Intellect.
5. Edetate Calcium Disodium (CaNa2EDTA): AccessPharmacy.