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 four branded drugs marketed by Gd Searle Llc, Coopersurgical, and Radiomedix, and is included in four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for copper. One supplier is listed for this compound.

Summary for COPPER

US Patents:	3
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2869
Clinical Trials:	162
Patent Applications:	443
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

^*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
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
Nanfang Hospital, Southern Medical University	Phase 2
Bhabha Atomic Research Centre (BARC)	Phase 2

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
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Gd Searle Llc	CU-7	copper	INTRAUTERINE DEVICE;INTRAUTERINE	017408-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Coopersurgical	PARAGARD T 380A	copper	SYSTEM;INTRAUTERINE	018680-001	Nov 15, 1984		RX	Yes	Yes
Gd Searle Llc	TATUM-T	copper	INTRAUTERINE DEVICE;INTRAUTERINE	018205-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Radiomedix	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
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
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