FDA Orange Book
Is there a generic for Akten?
Akten contains lidocaine. 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 Akten (lidocaine). The Orange Book shows its last listed patent expires July 24, 2026.
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Akten products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, ophthalmic | 3.5% | Marketed (Rx) | None | 0 | None |
NDA 022221, held by THEA PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Akten patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8759401 | July 24, 2026 | Drug product | U-1523 | 022221 |
Akten NDC codes
Questions
Is there a generic for Akten?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Akten (lidocaine). The Orange Book shows its last listed patent expires July 24, 2026.
What is the generic name for Akten?
The active ingredient in Akten is lidocaine, per the FDA Orange Book.
When does the Akten patent expire?
The last patent listed for Akten in the Orange Book expires July 24, 2026. 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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