Orange Book product · Brand (NDA)
DETECTNET
COPPER CU-64 DOTATATE
At a glance
Sep 03, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 03, 2020
5 yr 11 mo ago
Today
Exclusivity ends · ODE-317
Orphan-drug exclusivity (7 years)
Sep 03, 2027
in 1 yr 3 mo
Patent 10159759 expires
Listed method-of-use patent (U-2951) expiration.
Aug 23, 2032
in 6 yr 3 mo
Patent 11160888 expires
Listed method-of-use patent (U-2951) expiration.
Aug 23, 2032
in 6 yr 3 mo
Patent 10383961 expires
Listed method-of-use patent (U-2951) expiration.
Jul 02, 2033
in 7 yr 2 mo
Patent 12102696 expires
Listed drug product patent expiration.
Sep 03, 2041
in 15 yr 5 mo
Pharmaceutical detail
Active ingredient
COPPER CU-64 DOTATATE
Strength
4mL (1mCi/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 213227
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)
- ODE-317Orphan-drug exclusivity (7 years)
Sep 03, 2027
in 1 yr 3 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10159759 | Aug 23, 2032 | in 6 yr 3 mo | U-2951 |
| 11160888 | Aug 23, 2032 | in 6 yr 3 mo | U-2951 |
| 10383961 | Jul 02, 2033 | in 7 yr 2 mo | U-2951 |
| 12102696 | Sep 03, 2041 | in 15 yr 5 mo | Product |
