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FDA Orange Book · active-ingredient family

Copper

Copper is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MIUDELLA · NDA 218201

4

Brand (NDA)

0

Generics (ANDA)

14

Listed patents

2

Exclusivity periods

Brand (NDA) products · intrauterine device, system

ProductApplicantApplicationTEApproved
MIUDELLARLDSEBELA WOMENS HLTHNDA 218201—Feb 24, 2025
PARAGARD T 380ARLDCOOPERSURGICALNDA 018680—Nov 15, 1984
CU-7GD SEARLE LLCNDA 017408—Approved Prior to Jan 1, 1982
TATUM-TGD SEARLE LLCNDA 018205—Approved Prior to Jan 1, 1982

Marketing exclusivity (2)

  • NPNew product exclusivity (3 years)

    Feb 24, 2028

    in 1 yr 9 mo

  • D-193New indication / change exclusivity (3 years)

    Jun 28, 2027

    in 1 yr

Listed patents (14)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9427351Aug 14, 2032in 6 yr 3 mo
Product
11850181Aug 14, 2032in 6 yr 3 mo
Product
10188546Aug 14, 2032in 6 yr 3 mo
Product
10159596Aug 14, 2032in 6 yr 3 mo
Product
9089418Apr 09, 2033in 6 yr 11 mo
Product
12138199Oct 18, 2033in 7 yr 5 mo
Product
10398588Feb 24, 2034in 7 yr 10 mo
ProductU-4155
9610191Feb 24, 2034in 7 yr 10 mo
U-4155
10022264Mar 22, 2034in 7 yr 10 mo
Product
9180040Mar 22, 2034in 7 yr 10 mo
Product
9265652Apr 28, 2034in 8 yr
U-4155
10166141Jun 13, 2034in 8 yr 1 mo
Product
11207209Aug 16, 2034in 8 yr 3 mo
Product
10918516Jan 23, 2037in 10 yr 9 mo
Product

Copper — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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