FDA Orange Book
Generic for Kybella
Kybella contains deoxycholic acid. 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
Yes. The generic name for Kybella is deoxycholic acid. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Kybella products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 20MG/2ML (10MG/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 206333, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic deoxycholic acid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WILSHIRE PHARMACEUTICALS INC | 212296 | AP (A-rated, therapeutically equivalent) | April 2, 2021 | 20MG/2ML (10MG/ML) |
Kybella patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7754230 | December 10, 2027 | Method of use | U-1690 | 206333 |
| 7622130 | December 10, 2027 | Method of use | U-1690 | 206333 |
| 9949986 | February 21, 2028 | Method of use | U-1940 | 206333 |
| 9636349 | February 21, 2028 | Method of use | U-1940 | 206333 |
| 9522155 | February 21, 2028 | Drug product | U-1940 | 206333 |
| 8546367 | February 21, 2028 | Drug product | U-1690 | 206333 |
| 8461140 | February 21, 2028 | Drug product | None | 206333 |
| 8883770 | February 21, 2028 | Drug product | None | 206333 |
| 8242294 | May 16, 2028 | Drug substance | None | 206333 |
| 8653058 | March 2, 2030 | Drug product | None | 206333 |
| 8367649 | March 2, 2030 | Drug product | None | 206333 |
| 8101593 | March 2, 2030 | Drug product | None | 206333 |
| 10500214 | March 2, 2030 | Drug product | None | 206333 |
| 12161653 | February 17, 2032 | Method of use | U-1940 | 206333 |
Kybella NDC codes
Questions
Is there a generic for Kybella?
Yes. The generic name for Kybella is deoxycholic acid. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Kybella?
The active ingredient in Kybella is deoxycholic acid, per the FDA Orange Book.
When does the Kybella patent expire?
The last patent listed for Kybella in the Orange Book expires February 17, 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.