COPPER - Generic Drug Details

What are the generic sources for copper and what is the scope of freedom to operate?

Copper is the generic ingredient in five branded drugs marketed by Gd Searle Llc, Sebela Womens Hlth, Coopersurgical, and Curium, and is included in five NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Copper has twenty-nine patent family members in seven countries.

There are fifteen drug master file entries for copper. Two suppliers are listed for this compound.

Summary for COPPER

International Patents:	29
US Patents:	17
Tradenames:	5
Applicants:	4
NDAs:	5
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2869
Clinical Trials:	173
What excipients (inactive ingredients) are in COPPER?	COPPER excipients list
DailyMed Link:	COPPER at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COPPER

Constraining patent/regulatory exclusivity:

NEW INSERTER INTENDED TO FACILITATE SINGLE-HAND PLACEMENT

Dosage:

SYSTEM;INTRAUTERINE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SYSTEM;INTRAUTERINE

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for COPPER

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

Sponsor	Phase
Assiut University	NA
University Health Network, Toronto	PHASE1
M.D. Anderson Cancer Center	PHASE2

See all COPPER clinical trials

Pharmacology for COPPER

Drug Class	Copper-containing Intrauterine Device
Physiological Effect	Decreased Embryonic Implantation Decreased Sperm Motility Inhibit Ovum Fertilization

Medical Subject Heading (MeSH) Categories for COPPER

Trace Elements

US Patents and Regulatory Information for COPPER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes			Y
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes

Expired US Patents for COPPER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982

International Patents for COPPER

Country	Patent Number	Title	Estimated Expiration
Canada	3171011	DISPOSITIF CONTRACEPTIF INTRA-UTERIN (INTRAUTERINE CONTRACEPTIVE DEVICE)
Canada	3171011	DISPOSITIF CONTRACEPTIF INTRA-UTERIN (INTRAUTERINE CONTRACEPTIVE DEVICE)
Canada	2926210	DISPOSITIF INTRA-UTERIN A ELUTION D'ION DE CUIVRE REGULEE (INTRAUTERINE DEVICE WITH CONTROLLED COPPER ION ELUTION)

Market Dynamics and Financial Trajectory for Copper in Pharmaceutical Applications

Last updated: July 29, 2025

Introduction

Copper, an element with extensive industrial and medical applications, has gained increasing attention within the pharmaceutical sector owing to its antimicrobial and biological properties. Historically, copper's role has been predominantly industrial, but recent research underscores its potential as a critical component in pharmaceutical formulations, wound care, and anti-infective therapies. This article provides an in-depth analysis of the evolving market dynamics and financial trajectories associated with copper's pharmaceutical applications, offering vital insights for investors, manufacturers, and healthcare stakeholders.

Market Overview

Global Copper Market in Pharmaceuticals

While copper's traditional uses span plumbing, electronics, and construction, its pharmaceutical segment remains niche yet rapidly expanding. The rising prevalence of antimicrobial resistance (AMR), increasing demand for infection control products, and innovations in copper-based biomedical devices are primary catalysts driving growth. According to market reports, the global copper market was valued at approximately USD 8 billion in 2022, with an anticipated compound annual growth rate (CAGR) of 6-8% through 2030, partly fueled by pharmaceutical applications.

Key Drivers

• Antimicrobial Properties: Copper's ability to kill bacteria, fungi, and viruses through contact killing mechanisms propels its adoption in hospital surfaces, wound dressings, and medical devices, especially crucial amid COVID-19 pandemic disruptions [1].
• Rising Chronic Diseases: An aging population predisposes to infections and wound management that benefit from copper-based treatments.
• Regulatory Endorsements: Agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recognize copper’s medical potential, facilitating market entry.
• Innovation in Copper-Infused Products: The development of copper-infused fabrics, wound dressings, and surgical tools bolster demand.

Challenges

• Regulatory Hurdles: Ensuring safety and efficacy standards delays commercialization.
• Manufacturing Costs: Complex synthesis and quality control increases capital expenditure.
• Competition: Alternative antimicrobial agents, such as silver and antibiotics, compete within the same scope.

Market Segmentation and Application Analysis

Pharmaceutical Formulations

Copper ions are increasingly incorporated into drugs aimed at antimicrobial action, anti-inflammatory therapy, and wound healing.

Medical Devices and Equipment

Copper's incorporation into hospital surfaces and devices reduces microbial burden, decreasing hospital-acquired infections (HAIs). The global market for antimicrobial surfaces is projected to grow significantly, with copper leading the segment.

Wound Care and Dressings

Copper-infused dressings are gaining popularity for chronic wounds such as diabetic foot ulcers, with clinical evidence supporting their efficacy [2].

Research and Development

Investments in R&D focus on nanoparticle delivery systems, copper chelates, and biocompatible alloys, potentially expanding future applications.

Financial Trajectory and Investment Outlook

Market Growth Projections

The pharmaceutical segment's contribution to copper revenues is expected to witness a CAGR of around 7% over the next decade, driven by novel formulations and growing healthcare expenditure.

Key Companies and Investment Opportunities

Leading firms like Johnson & Johnson, Coloplast, and smaller biotech startups focus on copper-based bioactive materials. Patent filings related to copper formulations surged by over 20% annually from 2018 to 2022, indicating robust innovation activity.

Revenue Streams

• Product Sales: Wound dressings, medical device coatings, and topical formulations.
• Licensing & Collaborations: Partnerships between pharmaceutical companies and materials scientists accelerate commercialization.
• Material and Raw Product Sales: Copper sourcing and manufacturing equipment provide ancillary revenue.

Emerging Trends

• Nanotechnology Integration: Copper nanoparticles enhance antimicrobial efficacy, promising higher market penetration.
• Sustainable Manufacturing: Eco-friendly production methods align with pharmaceutical industry sustainability goals.
• Personalized Medicine: Copper-based biomaterials tailored to patient-specific needs represent a horizon-expanding frontier.

Regulatory Landscape and Impact on Financial Trajectory

Regulatory acknowledgment significantly influences market dynamics. The recent designation of copper-infused wound dressings as medical devices in the U.S. and EU expedites approval pathways, reducing time-to-market and boosting revenues. Conversely, regulatory delays can hamper growth prospects.

Market Challenges and Risk Factors

• Regulatory Uncertainty: Divergent international standards may impose compliance costs.
• Safety Concerns: Potential toxicity from excessive copper exposure necessitates rigorous safety assessments.
• Competitive Landscape: Silver-based antimicrobials and emerging biocidal compounds pose competitive threats.
• Supply Chain Disruptions: Fluctuations in copper prices affect margins, especially with geopolitical tensions impacting mining regions.

Future Outlook

The integration of copper in pharmaceuticals is poised to expand, backed by increasing scientific validation and technological innovation. The trajectory suggests sustained growth in revenue streams, with particular emphasis on nanoparticle applications and antimicrobial devices. Companies investing in R&D and regulatory navigation are positioned to capitalize on these trends.

Key Takeaways

• Copper's antimicrobial and therapeutic properties are catalyzing a niche but high-growth pharmaceutical segment.
• The market is driven by increasing antimicrobial resistance, aging populations, and innovation in biomedical materials.
• Investment prospects are promising, with potential revenue growth and innovation-driven expansion.
• Regulatory clarity and safety assurance remain critical to unlocking further market potential.
• Strategic collaborations and technological advancements, notably in nanotechnology, can significantly influence the financial trajectory.

Conclusion

Copper's evolution from industrial mainstay to a promising pharmaceutical ingredient signals a compelling growth narrative within the health sector. With dedicated R&D, regulatory alignment, and strategic alliances, stakeholders can realize substantial financial gains while advancing healthcare innovations.

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FAQs

1. What are the primary pharmaceutical applications of copper?
Copper is chiefly used in antimicrobial wound dressings, medical device coatings, and topical formulations with anti-inflammatory and antimicrobial properties.

2. How does copper compare to other antimicrobial metals like silver?
Copper offers cost advantages, sustained antimicrobial activity, and fewer resistance issues compared to silver. Its broader applicability in surface coatings and ease of integration into various formulations enhance its market position.

3. What regulatory hurdles exist for copper-based pharmaceuticals?
Regulatory agencies require comprehensive safety, efficacy, and biocompatibility data. Variability across jurisdictions may extend approval timelines and influence market entry.

4. Is the market for copper in pharmaceuticals expected to grow uniformly across regions?
Growth potential is higher in North America and Europe due to advanced healthcare infrastructure and greater regulatory acceptance. Emerging markets are adopting copper applications, albeit at a slower pace, driven by increasing healthcare investments.

5. What innovations are shaping the future of copper in medicine?
Nanoparticle formulations, copper-chelating drug delivery systems, and biodegradable copper alloys are at the forefront, promising enhanced efficacy and safety profiles.

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References

[1] Lan, G., et al. (2018). "Antimicrobial activity of copper surfaces." Journal of Hospital Infection, 98(3), 244-251.

[2] Prasad, S., et al. (2020). "Copper-infused dressings: A new paradigm in wound management." Advances in Wound Care, 9(5), 215-223.