FDA Orange Book
Is there a generic for Iluvien?
Iluvien contains fluocinolone acetonide. 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 Iluvien (fluocinolone acetonide). The Orange Book shows its last listed patent expires November 7, 2028.
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Iluvien products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| implant, intravitreal | 0.19MG | Marketed (Rx) | None | 0 | None |
NDA 201923, held by ALIMERA SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Iluvien patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8871241 | August 12, 2027 | Drug product | None | 201923 |
| 9849027 | November 7, 2028 | Drug product | U-708 | 201923 |
| 9849027 | November 7, 2028 | Drug product | U-4157 | 201923 |
Iluvien NDC codes
Questions
Is there a generic for Iluvien?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Iluvien (fluocinolone acetonide). The Orange Book shows its last listed patent expires November 7, 2028.
What is the generic name for Iluvien?
The active ingredient in Iluvien is fluocinolone acetonide, per the FDA Orange Book.
When does the Iluvien patent expire?
The last patent listed for Iluvien in the Orange Book expires November 7, 2028. 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.