Lead Chelator Drug Class List

Drugs in Drug Class: Lead Chelator

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	EDETATE CALCIUM DISODIUM	edetate calcium disodium	INJECTABLE;INJECTION	216435-001	May 3, 2023		RX	No	Yes
Hameln	PENTETATE CALCIUM TRISODIUM	pentetate calcium trisodium	SOLUTION;INHALATION, INTRAVENOUS	021749-001	Aug 11, 2004		DISCN	Yes	No
Jubilant	DRAXIMAGE DTPA	technetium tc-99m pentetate kit	INJECTABLE;INJECTION	018511-001	Dec 29, 1989		RX	Yes	Yes
Recordati Rare	CHEMET	succimer	CAPSULE;ORAL	019998-002	Jan 30, 1991		RX	Yes	Yes
Theragnostics	NEPHROSCAN	technetium tc-99m succimer	POWDER;INTRAVENOUS	214993-001	Feb 18, 2022		RX	Yes	Yes

Lead Chelator Market Analysis and Financial Projection

The market dynamics and patent landscape for lead chelators reveal a complex interplay of growing therapeutic demand, persistent supply challenges, and evolving innovation strategies. Below is a structured analysis:

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Market Dynamics

1. Growth Drivers

• The global lead poisoning treatment market is projected to reach $9 billion by 2034 (CAGR: 4.01%–5.30%), driven by rising awareness of lead toxicity and environmental regulations[7][10].
• Chelation therapy dominates treatment approaches, accounting for 43.4% of the heavy metal poisoning treatment market[14]. North America holds a 42.1% market share, fueled by R&D investments and product launches like Fe Pharmaceuticals’ DIBI[2][14].

2. Supply Challenges

• Persistent shortages: 13 lead chelator shortages occurred between 2001–2022, with median durations increasing from 3 to 11 months. Parenteral agents (e.g., calcium disodium edetate) faced longer shortages (14.2 months) than oral agents (2.2 months)[1][3].
• Generic dominance: All shortages involved single-source, generic products. Manufacturing issues (e.g., Recordati’s 2021 succimer shortage[5]) and financial pressures on generics (low profitability, regulatory costs) exacerbate vulnerabilities[1][3].

3. Clinical and Regulatory Factors

• Chelation decisions depend on blood lead levels (BLL ≥45 µg/dL), exposure sources, and patient factors[5].
• Regulatory hurdles (e.g., FDA oversight) and competition from overseas generics limit market entry, creating dependency on few suppliers[1].

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Patent Landscape

1. Key Innovations

• Novel chelators: Fe Pharmaceuticals’ DIBI (U.S. Patent No. 12,024,490) combines iron-chelation with anti-infective properties, targeting antimicrobial resistance[2].
• Formulation advances: Patents cover oral chelators (e.g., EDTA-NAC combinations[9]) and radiometal-binding agents (e.g., WO2021168567A1 for actinium-225[8]).

2. Strategic Trends

• Non-traditional applications: Patents extend into battery regeneration (US20230352649A1 uses EDTA to dissolve lead sulfate[13]) and drug repurposing (e.g., dimercaprol for Wilson’s disease[12]).
• Competitive pressures: Lead compound analyses in chemical patents are declining, as courts prioritize prior art over traditional modifications[4].

3. Barriers to Entry

• Patent cliffs: Targets like secretases and neutrophil elastase see reduced filings after clinical trial failures[6].
• Research-to-patent lag: A 5-year gap exists between academic research and patent filings, delaying commercialization[6].

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Comparative Analysis

Factor	Market Impact	Patent Trends
Demand	Rising due to environmental lead exposure and regulatory action[10][14].	New patents focus on niche applications (e.g., radiometals, infections)[2][8].
Supply	Shortages driven by single-source generics and manufacturing issues[1][5].	Limited novel chelator patents; incremental formulation improvements dominate[9].
Regulation	FDA oversight raises compliance costs but ensures quality[1][5].	Legal shifts reduce reliance on lead compound analyses, favoring prior art[4].
Innovation	DIBI’s dual-purpose chelation highlights anti-infective potential[2].	Cross-industry patents (e.g., batteries) diversify chelator use cases[13].

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Future Outlook

• Market resilience: Requires diversified manufacturing, public-private partnerships, and guidelines for shortage management[3].
• Innovation opportunities: Non-antibiotic chelators (e.g., DIBI) and repurposed agents could address antimicrobial resistance and unmet needs[2][12].
• Geographic expansion: Emerging markets in Asia and Africa may drive growth due to higher lead exposure rates[10][14].

“DIBI interrupts infections without drug resistance emerging, offering a breakthrough in chelation therapy.” – Fe Pharmaceuticals (2024)[2].

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This landscape underscores the critical balance between addressing urgent public health needs and fostering sustainable innovation in a challenging regulatory and economic environment.

References

1. https://pmc.ncbi.nlm.nih.gov/articles/PMC11163907/
2. https://fepharm.com/post/fe-pharmaceuticals-announces-issuance-of-new-u-s-patent-for-its-lead-product-dibi
3. https://pubmed.ncbi.nlm.nih.gov/38863853/
4. https://www.ipupdate.com/2024/12/chromatographic-clash-when-is-a-lead-compound-analysis-even-necessary/
5. https://archive.cdc.gov/www_cdc_gov/nceh/lead/news/succimer-drug-shortage.html
6. https://www.biorxiv.org/content/10.1101/2023.02.10.527980v3.full-text
7. https://www.marketresearchfuture.com/reports/lead-poisoning-treatment-market-37679
8. https://patents.google.com/patent/WO2021168567A1/en
9. https://patents.google.com/patent/CA2311024C/en
10. https://www.databridgemarketresearch.com/reports/global-lead-poisoning-treatment-market
11. https://pubmed.ncbi.nlm.nih.gov/1663439/
12. https://en.wikipedia.org/wiki/Dimercaprol
13. https://patents.google.com/patent/US20230352649A1/en
14. https://www.datamintelligence.com/research-report/heavy-metal-poisoning-treatment-market