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 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 thirty 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:	30
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:

11,207,209

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
Sebela Womens Hlth	MIUDELLA	copper	SYSTEM;INTRAUTERINE	218201-001	Feb 24, 2025		RX	Yes	Yes	10,022,264		Y
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Sentynl Theraps Inc	ZYCUBO	copper histidinate	POWDER;SUBCUTANEOUS	211241-001	Jan 12, 2026		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	3,783,861
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	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	3,563,235

International Patents for COPPER

Country	Patent Number	Title	Estimated Expiration
Canada	2926210	DISPOSITIF INTRA-UTERIN A ELUTION D'ION DE CUIVRE REGULEE (INTRAUTERINE DEVICE WITH CONTROLLED COPPER ION ELUTION)
Mexico	374834	DISPOSITIVO INTRAUTERINO CON HILO DE RECUPERACION. (INTRAUTERINE DEVICE WITH RETRIEVAL THREAD.)
Spain	2685294

Market Dynamics and Financial Trajectory for Copper Pharmaceuticals

Last updated: April 26, 2026

Copper is not a single, branded prescription drug; it is a chemical element used across a spectrum of pharmaceutical products. Market dynamics and financial trajectory therefore depend on the specific copper-based therapy: copper salts for nutrition and deficiency states, and copper chelation products for copper overload diseases. “Copper” as an investment thesis only holds if the product is identified by active ingredient, indication, and regulatory status.

What copper-linked pharmaceutical products drive revenue today?

Copper-linked pharmaceuticals fall into two commercial buckets with opposite demand drivers:

1) Copper supplementation (treat deficiency and nutritional copper needs)

• Demand drivers
  • Prevalence of copper deficiency in specific settings (malabsorption, bariatric surgery sequelae, total parenteral nutrition protocols)
  • Product availability and supply continuity of copper salts for enteral or parenteral use
  • Clinical guideline alignment and hospital formulary adoption
• Typical market structure
  • More generic-like procurement for copper salts where standardized solutions or salts are interchangeable
  • Contract manufacturing and tender-driven purchasing

2) Copper chelation (treat Wilson disease and other copper overload conditions)

• Demand drivers
  • Patient diagnosis and ongoing therapy in chronic genetic disease
  • Treatment adherence and long-term prescribing patterns
  • Uptake versus competing chelators
  • Safety tolerability profile impacting switching and persistence

Key point for financial trajectory

• Supplementation products tend to show pricing pressure and procurement-driven revenue.
• Chelators can show stronger retention economics because therapy is chronic and regimen-specific.

Which specific “copper” medicines are most relevant to financial forecasting?

Commonly commercialized copper-based therapies include:

• Penicillamine (copper chelator; Wilson disease)
• Trientine (copper chelator; Wilson disease)
• Tetrathiomolybdate (copper chelator platform; copper overload settings)
• Copper salts (for deficiency/nutritional replacement in drug and nutrition contexts)

These products produce the most material “financial trajectory” outcomes because their markets are tied to identifiable indications with defined dosing and long-term treatment schedules.

How do market dynamics differ across copper chelators vs supplementation?

Copper chelation: pricing power tied to chronic disease and tolerability

Key market mechanics:

• Diagnosis funnel: Revenue depends on identifying eligible patients and keeping them on therapy.
• Switching events: Side effects and intolerance drive switching among chelators, which can shift market share.
• Persistence: Chronic dosing increases lifetime value for successful therapies.
• Competition: Limited number of chelators plus country-specific formularies creates pockets of durable share.

Copper supplementation: revenue tied to institutional purchasing and generic interchangeability

Key market mechanics:

• Tender and bulk procurement: Revenue often depends on contract wins rather than premium pricing.
• Supply continuity: Shortages can swing near-term sales across suppliers.
• Interchangeability: Lower pricing power when copper salts are treated as commodity-like inputs.

What are the headline financial trajectory patterns for copper-linked pharmaceuticals?

Without mapping “copper” to a specific drug and geography, the cleanest financial trajectory generalizations are these:

Copper chelators

• Revenue trajectory often shows:
  • Steady growth with diagnosis expansion and improved screening
  • Modest volatility around safety-driven label events or competitive switching
  • Discounting and lifecycle effects as patents expire or generics enter
• Typical inflection points:
  • Formulary inclusion changes at major payer levels
  • New formulations that improve adherence
  • Trial readouts in broader indications

Copper supplementation

• Revenue trajectory often shows:
  • Flat to incremental growth aligned to hospital utilization and supply contracts
  • Pricing pressure from generic competition
  • Periodic disruptions from manufacturing constraints
• Typical inflection points:
  • Changes in nutrition protocols for parenteral formulations
  • Regulatory or quality issues impacting supply

How should investors or R&D teams translate “copper” into a financial model?

A workable financial model for copper-linked therapies must segment by:

1. Product type

   • Chelation (penicillamine, trientine, tetrathiomolybdate)
   • Supplementation (copper salts)

2. Indication

   • Wilson disease (most mature copper-chelation market)
   • Other copper overload states (more variable adoption)

3. Pricing structure

   • Retail/payer reimbursement for branded or protected products
   • Tender-based purchasing for salts and generic-like products

4. Geography

   • Prescribing practices and reimbursement differ materially by region

Without these segmentation layers, “copper” cannot be responsibly tied to a single market size, growth rate, or profit trajectory.

What regulatory and clinical factors shape revenue durability in copper therapy?

Copper chelation:

• Chronic therapy duration supports revenue persistence.
• Safety profiles (notably with older chelators like penicillamine) can affect:
  • Switching rates
  • Adherence and dose modifications
  • Clinician preference by patient subgroup

Copper supplementation:

• Clinical outcomes depend on dosing accuracy and absorption context.
• Hospital protocol adherence drives utilization.
• Supply reliability influences continuity of therapy and can affect purchasing patterns.

How do competitive dynamics typically play out in copper chelation?

Copper chelation competition typically centers on:

• Tolerability and adverse event profiles
• Dosing practicality
• Clinician familiarity
• Access through formularies

For Wilson disease specifically, multiple chelators exist, so market share shifts follow real-world prescribing and payer coverage rather than purely efficacy differentiation.

What is the realistic investment takeaway on “copper” as a market?

Treat “copper” as an input category, not a tradable product category. Financial trajectory depends on which copper-linked medicine you mean. The only defensible market view is product-specific:

• If the thesis is chelation (Wilson disease), the market behaves like a chronic specialty drug market with:
  • Higher persistence
  • Competition centered on tolerability and access
• If the thesis is supplementation, the market behaves more like:
  • A procurement and supply chain market
  • Lower pricing power and more generic-like dynamics

Key Takeaways

• “Copper” is a category spanning supplementation and chelation, with opposite demand and pricing mechanics.
• Copper chelation products align with chronic disease economics and typically show more durable revenue persistence than copper salts.
• Copper supplementation is more procurement-driven and tends to face stronger pricing pressure and interchangeability.
• Any financial trajectory assessment must be anchored to the specific copper-linked active ingredient, indication, and geography, not the element category.

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FAQs

1) Is “copper” a single pharmaceutical market?

No. “Copper” maps to multiple medicines and product classes, including copper chelators for copper overload and copper salts for deficiency states.

2) Which copper therapies typically have stronger revenue persistence?

Copper chelators used for chronic indications such as Wilson disease typically have more persistent demand than supplementation products.

3) What most influences copper-chelation market share?

Real-world prescribing patterns driven by tolerability, clinician familiarity, and payer formularies generally drive switching and share.

4) Why does copper supplementation revenue often face pricing pressure?

Copper salts are frequently treated as interchangeable inputs in clinical nutrition, enabling generic competition and tender-based purchasing.

5) What is the best way to model the financial trajectory of copper therapies?

Model by active ingredient, indication, treatment duration, pricing structure (reimbursed vs tender), and geography rather than by “copper” category alone.

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References

[1] United States Food and Drug Administration (FDA). Wilson disease treatment information and medical reviews (varies by product). FDA Drug Safety and Approval databases. https://www.fda.gov/
[2] European Medicines Agency (EMA). Wilson disease and copper chelation medicinal product information. https://www.ema.europa.eu/
[3] PubMed. Clinical reviews and comparative studies on copper chelation therapies in Wilson disease. https://pubmed.ncbi.nlm.nih.gov/
[4] National Organization for Rare Disorders (NORD). Wilson disease overview and treatment approaches. https://rarediseases.org/