FDA Orange Book
Is there a generic for Spy Agent Green Kit?
Spy Agent Green Kit contains indocyanine green. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Spy Agent Green Kit (indocyanine green). The Orange Book shows its last listed patent expires July 14, 2039 and its last listed exclusivity ends June 5, 2026.
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Spy Agent Green Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous, interstitial | 25MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 211580, held by NOVADAQ TECHNOLOGIES ULC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Spy Agent Green Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8185176 | June 4, 2028 | Method of use | U-2462 | 211580 |
| 8647605 | February 11, 2029 | Method of use | U-2468 | 211580 |
| 8647605 | February 11, 2029 | Method of use | U-2464 | 211580 |
| 8406860 | April 9, 2029 | Method of use | U-2463 | 211580 |
| 10631746 | August 4, 2035 | Drug product | U-2815 | 211580 |
| 11712320 | July 14, 2039 | Drug product | None | 211580 |
Spy Agent Green Kit exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-911 | New indication | June 5, 2026 | 211580 |
Questions
Is there a generic for Spy Agent Green Kit?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Spy Agent Green Kit (indocyanine green). The Orange Book shows its last listed patent expires July 14, 2039 and its last listed exclusivity ends June 5, 2026.
What is the generic name for Spy Agent Green Kit?
The active ingredient in Spy Agent Green Kit is indocyanine green, per the FDA Orange Book.
When does the Spy Agent Green Kit patent expire?
The last patent listed for Spy Agent Green Kit in the Orange Book expires July 14, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.