Copper Chelator Drug Class List

Drugs in Drug Class: Copper Chelator

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211076-001	Jul 3, 2019	AB	RX	No	No
Endo Operations	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	210096-001	Sep 25, 2019	AB	RX	No	No
Navinta Llc	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	211251-001	Jan 16, 2019	AB	RX	No	No
Orphalan	CUVRIOR	trientine tetrahydrochloride	TABLET;ORAL	215760-001	Apr 28, 2022		RX	Yes	Yes
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-001	Feb 20, 2020	AB	RX	No	No
Rising	TRIENTINE HYDROCHLORIDE	trientine hydrochloride	CAPSULE;ORAL	212238-002	Sep 22, 2023		RX	No	No

Copper Chelator Market Analysis and Financial Projection

The market for copper chelator drugs is experiencing significant growth due to rising disease prevalence, innovation in targeted therapies, and expanding therapeutic applications. Below is a detailed analysis of key dynamics shaping this niche pharmaceutical sector:

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Market Size and Growth Projections

• The Wilson’s Disease Treatment Market (copper chelators’ primary application) reached $1.2 billion in 2024 and is projected to grow at a 9.2% CAGR to $2.5 billion by 2033[9]. This growth is driven by:
  • Improved diagnostic rates for Wilson’s disease (1 in 30,000 prevalence globally)[12].
  • Demand for safer alternatives to traditional chelators like penicillamine, which causes severe side effects in 30% of patients[13].
  • Expansion into agricultural and aquaculture applications, though drug development remains focused on human therapeutics[1][5].

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Key Therapeutic Agents and Competition

• Trientine hydrochloride dominates the market as a first-line treatment, with:
  • 15 NDAs and 376 patent applications filed globally[10].
  • Generic competition from 73 bulk API suppliers, contributing to price pressures[10][12].
• Emerging alternatives include:
  • TDMQ20, a next-generation chelator showing 55% higher efficacy than D-penicillamine in murine models[13].
  • Liver-targeted chelators from the COPDETOX project, designed to minimize systemic toxicity[3].

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Patent Landscape and Innovation

Aspect	Details
Core Patents	Focused on molecule specificity (e.g., US20100256034A1 for cleaning agents)[6] and delivery mechanisms (e.g., COPDETOX liver-targeted chelators)[3].
Trends	Shift toward covalent drug discovery, though copper chelators represent <5% of 2020-23 covalent drug patents[4].
Evergreening Strategies	Limited due to generic dominance; only 3 tradenames exist for trientine[10].
Geographic Focus	61.5% of recent clinical trials led by U.S. and European institutions[10][13].

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Challenges and Market Barriers

1. Cost Constraints:

   • Annual treatment costs exceed $25,000 for branded therapies, limiting access in developing markets[12].
   • Generic penetration reduces prices but causes 14.2-month shortages for parenteral chelators[11].

2. R&D Limitations:

   • Only 13 active clinical trials for copper chelators globally[10].
   • Metal selectivity remains problematic—current chelators interact with zinc, iron, and cobalt ions[13].

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Future Outlook

• Precision Chelators: Projects like TDMQ20 aim to achieve log K values >18 for copper-specific binding[13].
• Patent Opportunities: 71% of recent innovations focus on reducing neurological side effects during decoppering[3][13].
• Market Expansion: Growing off-label use in oncology (copper’s role in tumor angiogenesis)[2] could drive 5.3% CAGR in agricultural chelate adjacencies[5].

“The COPDETOX project has validated liver-targeted chelators in vivo, marking a paradigm shift in copper overload management.”[3]

This sector’s evolution hinges on balancing generic affordability with patented innovations in metal specificity and delivery systems. While current growth is稳健, breakthroughs in covalent targeting and organ-selective chelation could unlock 15-20% premium pricing tiers by 2030.

References

1. https://www.thebusinessresearchcompany.com/report/chelated-minerals-global-market-report
2. https://pmc.ncbi.nlm.nih.gov/articles/PMC11433910/
3. https://anr.fr/Project-ANR-11-EMMA-0025
4. https://pubmed.ncbi.nlm.nih.gov/39219095/
5. https://www.grandviewresearch.com/industry-analysis/agricultural-chelates-market-report
6. https://patents.google.com/patent/US20100256034A1/en
7. https://www.rxlist.com/copper_chelators/drug-class.htm
8. https://www.pharmafocuseurope.com/articles/drug-patents-shape-pharma-competition
9. https://www.verifiedmarketreports.com/product/wilsons-disease-treatment-market/
10. https://www.drugpatentwatch.com/p/generic-api/trientine+hydrochloride
11. https://pmc.ncbi.nlm.nih.gov/articles/PMC11163907/
12. https://www.coherentmarketinsights.com/market-insight/wilsons-disease-treatment-market-526
13. https://pmc.ncbi.nlm.nih.gov/articles/PMC10747306/