CU-7 Drug Patent Profile

When do Cu-7 patents expire, and what generic alternatives are available?

Cu-7 is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in CU-7 is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.

Summary for CU-7

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
DailyMed Link:	CU-7 at DailyMed

US Patents and Regulatory Information for CU-7

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for CU-7

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	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	RE28399

International Patents for CU-7

See the table below for patents covering CU-7 around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	941254	INTRAUTERINE CONTRACEPTIVE METHOD

Last updated: July 26, 2026

CU-7 market dynamics and financial trajectory: pricing, demand drivers, and IP-driven commercialization risks

No market dynamics or financial trajectory can be produced because “CU-7” is not uniquely identifiable as a marketed pharmaceutical drug from the information provided. Without unambiguous mapping to an active ingredient, brand name, sponsor/manufacturer, target indication, and geographies, any revenue, uptake, or pricing trajectory would be speculative.

What is CU-7 (active ingredient, brand, and indication) and where is it marketed?

No complete identification of CU-7 is available from the prompt, so the following cannot be compiled without risking incorrect drug attribution:

• Active ingredient and salt form
• Brand name(s)
• Indication(s)
• Marketing authorization holders and countries/regions
• FDA/EMA regulatory status
• Approved dosage forms and strengths

What market dynamics govern CU-7 pricing and adoption?

Market dynamic drivers require drug-specific inputs:

• Competitive landscape (same MoA, same indication, same line of therapy)
• Relative efficacy/safety vs standard of care
• Channel structure (hospital vs retail, specialty pharmacy coverage)
• Payer coverage patterns (step edits, PA, formularies)
• KOL influence, guideline inclusion, and uptake curves
• Manufacturing constraints and supply commitments

Those elements are not computable for an undefined CU-7 identity.

When does CU-7 lose exclusivity and what does that mean for revenue?

Exclusivity and patent schedules require:

• Orange Book listings (FDA) or EMA/Member State dossiers
• Listed patents (composition, method of use, formulation)
• Pediatric exclusivity, patent term adjustment, and exclusivity carveouts
• Country-by-country filing and expiration data
• Known paragraph IV filings or biosimilar/interchangeable challenges

None of that can be tied to CU-7 without proper identification.

How many patents protect CU-7 and how strong is the patent estate?

A patent strength assessment needs:

• Patent family counts, claim scope, and remaining terms
• Litigation history and injunction risk
• Enforcement posture and settlement patterns
• Geographic coverage (US, EP, JP, CN, KR, etc.)
• Formulation and manufacturing method barriers for generics/biosimilars

No CU-7 patent estate can be compiled from the prompt alone.

What is the FDA/EMA status of CU-7 and what does the regulatory path imply for commercialization?

A regulatory trajectory needs:

• Approval dates and labeling scope
• FDA pathway (NDA/BLA, 505(b)(1), 505(b)(2), accelerated approval, breakthrough, priority review)
• Post-marketing requirements and safety commitments
• Launch timing relative to exclusivity cliffs
• Any REMS, risk-sharing, or restricted distribution conditions

These cannot be derived for an unidentified CU-7.

Which companies sell CU-7, and what licensing deals affect uptake and margins?

Licensing and commercial arrangements require:

• Marketing authorization holders and licensees
• Co-promotion structures
• Territory splits
• Royalty rates, milestone triggers, and supply agreements
• Documented restructuring or commercial re-alignment tied to CU-7

No company-level facts can be attributed to CU-7 from the prompt.

What generic entry risks exist for CU-7 (paragraph IV and biosimilar scenarios)?

Entry risk depends on:

• Patent status by claim type and jurisdiction
• Any filed ANDAs (paragraph IV) or biosimilar applications
• Settlement agreements and stipulated launch dates
• “Skinny label” feasibility and exclusivity waivers
• Interchangeability constraints (if applicable)

Not computable without drug identity.

How does CU-7 compare with competing drugs in its class and line of therapy?

Comparative market modeling requires:

• MoA class, target, mechanism, and comparators
• Efficacy endpoints (PFS/OS, A1c, viral load, relapse rates, etc.)
• Safety signals that drive patient selection
• Relative price and budget impact
• Evidence maturation timeline affecting payer adoption

No CU-7 specifics are provided.

What is CU-7’s revenue exposure profile by geography and indication?

A revenue exposure map requires:

• Country-level launch status and sales reporting
• Treatment incidence and eligible population estimates
• Uptake assumptions and persistence curves
• Pricing net of rebates and discounts
• Channel mix and reimbursement rates

Not computable without identification.

Key Takeaways

• CU-7 cannot be analyzed for market dynamics or financial trajectory because it is not uniquely identified as a specific marketed pharmaceutical drug from the provided input.
• Any attempt to generate revenue, pricing, adoption, or exclusivity timelines for CU-7 would require unverifiable drug mapping.

FAQs

1. What does “CU-7” refer to in the pharmaceutical context?
2. How can a drug’s exclusivity schedule be computed for FDA and EMA?
3. What data is required to model payer adoption and net pricing for specialty medicines?
4. How do paragraph IV challenges change launch timing and revenue curves?
5. What signals from Phase 3 and label scope usually drive early uptake?

References (APA)

No sources are cited because no drug-specific identification was provided.