Orange Book product · Brand (NDA)
SPY AGENT GREEN KIT
INDOCYANINE GREEN
At a glance
Nov 21, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2018
7 yr 8 mo ago
Exclusivity ends · I-911
New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
Today
Patent 8185176 expires
Listed method-of-use patent (U-2462) expiration.
Jun 04, 2028
in 2 yr
Patent 8647605 expires
Listed method-of-use patent (U-2468) expiration.
Feb 11, 2029
in 2 yr 8 mo
Patent 8647605 expires
Listed method-of-use patent (U-2464) expiration.
Feb 11, 2029
in 2 yr 8 mo
Patent 8406860 expires
Listed method-of-use patent (U-2463) expiration.
Apr 09, 2029
in 2 yr 10 mo
Patent 10631746 expires
Listed drug product patent expiration.
Aug 04, 2035
in 9 yr 3 mo
Patent 11712320 expires
Listed drug product patent expiration.
Jul 14, 2039
in 13 yr 3 mo
Pharmaceutical detail
Active ingredient
INDOCYANINE GREEN
Strength
25MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS, INTERSTITIAL
TE code
Not listed
Application
NDA 211580
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)
- I-911New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8185176 | Jun 04, 2028 | in 2 yr | U-2462 |
| 8647605 | Feb 11, 2029 | in 2 yr 8 mo | U-2468 |
| 8647605 | Feb 11, 2029 | in 2 yr 8 mo | U-2464 |
| 8406860 | Apr 09, 2029 | in 2 yr 10 mo | U-2463 |
| 10631746 | Aug 04, 2035 | in 9 yr 3 mo | ProductU-2815 |
| 11712320 | Jul 14, 2039 | in 13 yr 3 mo | Product |
