Prescription medicine

Deoxycholic acid Brand names: Kybella

Deoxycholic acid (Kybella) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the deoxycholic acid FDA label on DailyMed (effective October 30, 2024, Kythera Biopharmaceuticals Inc.); the NDA 206333 record on Drugs@FDA; every deoxycholic acid label on DailyMed.

Highlights of the record

FDA label of October 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Forms and strengths

20 mg/2ml

Injection (solution).

On the market

Earliest approval on file: April 29, 2015 Kybella, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first April 2, 2021; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 17, 2032 Kybella injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 0 since 2020 0 Class I among all firms' recalls; 1 more by firms not listed as its makers

What is deoxycholic acid used for?

From the label: indications and usage
KYBELLA ® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Limitations of use The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. KYBELLA is a cytolytic drug indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. ( 1 ) Limit ations of use The safe and effective use of KYBELLA for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

FDA pharmacologic class: Cytolytic Agent.

Source: FDA drug label (KYBELLA), NDA206333 (Abbvie), as published by Kythera Biopharmaceuticals Inc., effective October 30, 2024 (SPL set fe431ed4-ea6f-4e99-b4bc-ec25ae7b8553), via openFDA; the full label on DailyMed

Is there a generic for deoxycholic acid (Kybella)?

The FDA approved the first generic deoxycholic acid on April 2, 2021. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

The Orange Book lists 14 patents for Kybella injection: the compound patent runs to May 16, 2028, and the last listed entry to February 17, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2015 earliest approval on file
2021 first generic approved
2032 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has deoxycholic acid been recalled?

The FDA's Enforcement Report lists 1 recall naming deoxycholic acid since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of deoxycholic acid and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
January 15, 2020	Class II	Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker	Lack of Assurance of Sterility

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What next?

Check an interaction: what two or more labels say about each other