FDA Orange Book
Is there a generic for Acuvail?
Acuvail contains ketorolac. 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 Acuvail (ketorolac). The Orange Book shows its last listed patent expires August 15, 2029.
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Acuvail products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.45% | Marketed (Rx) | None | 0 | None |
NDA 022427, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Acuvail patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8512717 | March 7, 2028 | Drug product | None | 022427 |
| 9192571 | March 7, 2028 | Drug product | None | 022427 |
| 7842714 | August 15, 2029 | Drug substance, Drug product | None | 022427 |
Acuvail NDC codes
Questions
Is there a generic for Acuvail?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Acuvail (ketorolac). The Orange Book shows its last listed patent expires August 15, 2029.
What is the generic name for Acuvail?
The active ingredient in Acuvail is ketorolac, per the FDA Orange Book.
When does the Acuvail patent expire?
The last patent listed for Acuvail in the Orange Book expires August 15, 2029. 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.
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