FDA Orange Book
Is there a generic for Acular Ls?
Acular Ls 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 Acular Ls (ketorolac). The Orange Book shows its last listed patent expires November 24, 2027.
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Acular Ls products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.4% | Marketed (Rx) | None | 0 | None |
NDA 021528, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Acular Ls patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8008338 | May 24, 2027 | Drug substance, Drug product | U-1181 | 021528 |
| 8008338*PED | November 24, 2027 | Method of use | None | 021528 |
Acular Ls NDC codes
Questions
Is there a generic for Acular Ls?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Acular Ls (ketorolac). The Orange Book shows its last listed patent expires November 24, 2027.
What is the generic name for Acular Ls?
The active ingredient in Acular Ls is ketorolac, per the FDA Orange Book.
When does the Acular Ls patent expire?
The last patent listed for Acular Ls in the Orange Book expires November 24, 2027. 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.
More on Acular Ls and Ketorolac
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- NDC 0023-9277Acular Ls NDC record