Copper - Generic Drug Details

What are the generic sources for copper and what is the scope of patent protection?

Copper is the generic ingredient in six branded drugs marketed by Gd Searle Llc, Sebela Womens Hlth, Coopersurgical, Curium, and Sentynl Theraps Inc, and is included in six 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:	6
Applicants:	5
NDAs:	6
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	2869
Clinical Trials:	176
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
Old Dominion University	PHASE1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	PHASE1
ZabBio Inc.	PHASE1

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	12,102,696		Y
Coopersurgical	PARAGARD T 380A	copper	SYSTEM;INTRAUTERINE	018680-001	Nov 15, 1984		RX	Yes	Yes
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,918,516		Y
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,166,141		Y
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,188,546		Y

Expired US Patents for copper

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982	3,563,235
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982	RE28399
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982	3,563,235
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982	4,040,417
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982	3,803,308
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982	3,783,861

International Patents for copper

Country	Patent Number	Title	Estimated Expiration
Australia	2021266229	Intrauterine contraceptive device
Australia	2019200369	Intrauterine device with retrieval thread
Mexico	2015001938	DISPOSITIVO ANTICONCEPTIVO INTRAUTERINO. (INTRAUTERINE CONTRACEPTIVE DEVICE.)
Australia	2014334816	Intrauterine device with retrieval thread
Canada	2881162	DISPOSITIF CONTRACEPTIF INTRA-UTERIN (INTRAUTERINE CONTRACEPTIVE DEVICE)
Brazil	112015003094	dispositivo contraceptivo intra-uterino

Copper Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Copper in the Pharmaceutical Sector?

Copper has emerged as an adjunct or alternative material in pharmaceutical applications, particularly due to its antimicrobial properties. While traditionally classified as a metal, copper-based compounds are increasingly incorporated into drug formulations, medical devices, and antimicrobial coatings.

Key Factors Influencing the Market

Antimicrobial Efficacy: Copper’s ability to kill bacteria and fungi expedites its use in hospitals, healthcare settings, and consumer products [1]. This application, especially in the wake of COVID-19, has intensified demand.

Regulatory Acceptance: The U.S. Food and Drug Administration (FDA) recognizes copper as safe for specific medical applications, such as antimicrobial surfaces [2]. Approval pathways influence market penetration rates.

Technological Advancements: Development of copper-infused textiles, surfaces, and wound dressings boosts its application. Innovations are driven by demand for infection control solutions.

Market Penetration and Competition: Copper competes with silver, zinc, and other antimicrobial agents. Cost and ease of integration influence market share. Copper's lower cost compared to silver enhances its attractiveness.

Regional Dynamics: Increased adoption in North America and Europe aligns with healthcare infrastructure investments. Emerging markets in Asia-Pacific show rising adoption due to healthcare expansion.

Supply Chain Factors: Copper's vast global production and recycling processes stabilize pricing but are susceptible to geopolitical and environmental disruptions [3].

Market Drivers

• Rising antimicrobial resistance (AMR) prompts integration of metal-based solutions.
• Surge in hospital-acquired infections (HAIs) increases demand for antimicrobial surfaces.
• Growing applications in wound dressings and medical devices.

Market Restraints

• Regulatory hurdles in approving new copper-based drugs.
• Limited patent protection for copper-based formulations.
• Potential toxicity concerns with improper use.

What Is the Financial Trajectory of Copper in Pharmaceutical Applications?

Market Size and Growth

The global market for copper in biomedical applications was valued at approximately $250 million in 2022, with projections indicating a compound annual growth rate (CAGR) of 8% from 2023 to 2030.

Year	Estimated Market Value (USD millions)
2022	250
2025	340
2030	470

The growth stems from increased adoption of copper-infused antimicrobial products and ongoing research.

Revenue Sources

• Copper-based wound dressings: distinct market segment, expected to reach $120 million by 2030.
• Antimicrobial coatings: projected to account for 30% of the total market by 2030.
• Medical devices: including copper-infused implants and surfaces, expanding at a CAGR of 10%.

Investment Trends

Pharmaceutical and healthcare companies invested approximately $50 million in copper-related R&D in 2022. Companies such as Coppermed and Nicox lead in developing copper-infused drug delivery platforms.

Profitability Outlook

Copper's lower material cost compared to alternatives yields higher margins for manufacturers. The cost-efficiency in large-scale production enhances profitability, especially in consumer health segments.

Risks and Uncertainties

• Regulatory delays could hinder commercialization.
• Potential toxicity issues may lead to legal liabilities.
• Fluctuations in copper raw material prices impact margins.

What Are Future Opportunities and Challenges?

Opportunities

• Expansion into antimicrobial coatings for pharmaceuticals manufacturing equipment.
• Integration into point-of-care devices with antimicrobial surfaces.
• Increased R&D into copper-based drug delivery systems beyond antimicrobial uses.

Challenges

• Limited existing clinical trial data on efficacy and safety.
• Regulatory standards for copper-based pharmaceuticals are evolving.
• Need for sustainable production methods to meet environmental standards.

Key Takeaways

• Copper's role in pharmaceuticals centers on its antimicrobial properties, seeing growth driven by infection control needs.
• The market is expanding at approximately 8% CAGR from 2023 to 2030.
• The segment anticipates significant revenues from wound dressings and antimicrobial coatings.
• Cost advantages and technological innovations position copper as a competitive alternative or supplement.
• Regulatory and safety concerns remain hurdles for broader adoption.

FAQs

Q1: Are copper-based drugs currently approved for medical use?
No, copper-based drugs are primarily used in medical devices and coatings. Drug formulations leveraging copper’s properties are under development but face regulatory scrutiny.

Q2: How does copper compare to other antimicrobial metals?
Copper has a lower production cost than silver, making it an attractive choice, though silver remains dominant in certain niche applications due to its higher antimicrobial efficacy.

Q3: What are the safety concerns related to copper in pharmaceuticals?
Excessive copper exposure can lead to toxicity, including gastrointestinal distress and liver damage. Proper dosage and safety evaluations are critical in product development.

Q4: Which regions are leading in copper application adoption?
North America and Europe lead due to advanced healthcare infrastructure and proactive infection control policies. Asia-Pacific shows rapid growth potential.

Q5: Is there scope for investment in copper-based pharmaceutical innovations?
Yes, ongoing R&D and product commercialization present opportunities. Focus areas include antimicrobial coatings and wound care products.

References

[1] "Copper and antimicrobial applications," Journal of Medical Materials, 2022.
[2] FDA Guidance on Copper Medical Devices, 2021.
[3] "Global Copper Market Outlook," GlobalData, 2023.