FDA Orange Book · active-ingredient family
Indocyanine green
Indocyanine green is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SPY AGENT GREEN KIT · NDA 211580
2
Brand (NDA)
1
Generics (ANDA)
5
Listed patents
1
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPY AGENT GREEN KITRLD | NOVADAQ TECH | NDA 211580 | — | Nov 21, 2018 | |
| IC-GREENRLD×4 | RENEW PHARMS | NDA 011525 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INDOCYANINE GREEN | RENEW PHARMS | ANDA 040811 | AP | Nov 21, 2007 |
Marketing exclusivity (1)
- I-911New indication exclusivity (3 years)
Jun 05, 2026
14 d ago
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8185176 | Jun 04, 2028 | in 2 yr | U-2462 |
| 8647605 | Feb 11, 2029 | in 2 yr 8 mo | U-2468 |
| 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 |
Indocyanine green — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
