FDA Orange Book
Is there a generic for Ilevro?
Ilevro contains nepafenac. 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 Ilevro (nepafenac). The Orange Book shows its last listed patent expires March 31, 2032.
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Ilevro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 0.3% | Marketed (Rx) | None | 0 | None |
NDA 203491, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ilevro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9662398 | December 1, 2030 | Drug product | None | 203491 |
| 8921337 | March 31, 2032 | Drug product | None | 203491 |
Ilevro NDC codes
Questions
Is there a generic for Ilevro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ilevro (nepafenac). The Orange Book shows its last listed patent expires March 31, 2032.
What is the generic name for Ilevro?
The active ingredient in Ilevro is nepafenac, per the FDA Orange Book.
When does the Ilevro patent expire?
The last patent listed for Ilevro in the Orange Book expires March 31, 2032. 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.