Orange Book product · Brand (NDA)
MIUDELLA
COPPER
At a glance
Feb 24, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 24, 2025
1 yr 4 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 24, 2028
in 1 yr 9 mo
Patent 10159596 expires
Listed drug product patent expiration.
Aug 14, 2032
in 6 yr 3 mo
Patent 10188546 expires
Listed drug product patent expiration.
Aug 14, 2032
in 6 yr 3 mo
Patent 11850181 expires
Listed drug product patent expiration.
Aug 14, 2032
in 6 yr 3 mo
Patent 9427351 expires
Listed drug product patent expiration.
Aug 14, 2032
in 6 yr 3 mo
Patent 9089418 expires
Listed drug product patent expiration.
Apr 09, 2033
in 6 yr 11 mo
Patent 12138199 expires
Listed drug product patent expiration.
Oct 18, 2033
in 7 yr 5 mo
Patent 10398588 expires
Listed drug product patent expiration.
Feb 24, 2034
in 7 yr 10 mo
Patent 9610191 expires
Listed method-of-use patent (U-4155) expiration.
Feb 24, 2034
in 7 yr 10 mo
Patent 10022264 expires
Listed drug product patent expiration.
Mar 22, 2034
in 7 yr 10 mo
Patent 9180040 expires
Listed drug product patent expiration.
Mar 22, 2034
in 7 yr 10 mo
Patent 9265652 expires
Listed method-of-use patent (U-4155) expiration.
Apr 28, 2034
in 8 yr
Patent 10166141 expires
Listed drug product patent expiration.
Jun 13, 2034
in 8 yr 1 mo
Patent 11207209 expires
Listed drug product patent expiration.
Aug 16, 2034
in 8 yr 3 mo
Patent 10918516 expires
Listed drug product patent expiration.
Jan 23, 2037
in 10 yr 9 mo
Pharmaceutical detail
Active ingredient
COPPER
Strength
N/A
Dosage form
SYSTEM
Route
INTRAUTERINE
TE code
Not listed
Application
NDA 218201
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Feb 24, 2028
in 1 yr 9 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10159596 | Aug 14, 2032 | in 6 yr 3 mo | Product |
| 10188546 | Aug 14, 2032 | in 6 yr 3 mo | Product |
| 11850181 | Aug 14, 2032 | in 6 yr 3 mo | Product |
| 9427351 | Aug 14, 2032 | in 6 yr 3 mo | Product |
| 9089418 | Apr 09, 2033 | in 6 yr 11 mo | Product |
| 12138199 | Oct 18, 2033 | in 7 yr 5 mo | Product |
| 10398588 | Feb 24, 2034 | in 7 yr 10 mo | ProductU-4155 |
| 9610191 | Feb 24, 2034 | in 7 yr 10 mo | U-4155 |
| 10022264 | Mar 22, 2034 | in 7 yr 10 mo | Product |
| 9180040 | Mar 22, 2034 | in 7 yr 10 mo | Product |
| 9265652 | Apr 28, 2034 | in 8 yr | U-4155 |
| 10166141 | Jun 13, 2034 | in 8 yr 1 mo | Product |
| 11207209 | Aug 16, 2034 | in 8 yr 3 mo | Product |
| 10918516 | Jan 23, 2037 | in 10 yr 9 mo | Product |
