KYBELLA — FDA application NDA206333
Listed sponsor: ABBVIE · ABBV company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | KYBELLA | DEOXYCHOLIC ACID | SOLUTION | SUBCUTANEOUS | 20MG/2ML (10MG/ML) | Prescription | AP | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 7622130 | 001 | listed patent expiry date: 2027-12-10 | U-1690 |
| Patent 7754230 | 001 | listed patent expiry date: 2027-12-10 | U-1690 |
| Patent 8461140 | 001 | listed patent expiry date: 2028-02-21 | drug product |
| Patent 8546367 | 001 | listed patent expiry date: 2028-02-21 | drug product, U-1690 |
| Patent 8883770 | 001 | listed patent expiry date: 2028-02-21 | drug product |
| Patent 9522155 | 001 | listed patent expiry date: 2028-02-21 | drug product, U-1940 |
| Patent 9636349 | 001 | listed patent expiry date: 2028-02-21 | U-1940 |
| Patent 9949986 | 001 | listed patent expiry date: 2028-02-21 | U-1940 |
| Patent 8242294 | 001 | listed patent expiry date: 2028-05-16 | drug substance |
| Patent 10500214 | 001 | listed patent expiry date: 2030-03-02 | drug product |
| Patent 8101593 | 001 | listed patent expiry date: 2030-03-02 | drug product |
| Patent 8367649 | 001 | listed patent expiry date: 2030-03-02 | drug product |
| Patent 8653058 | 001 | listed patent expiry date: 2030-03-02 | drug product |
| Patent 12161653 | 001 | listed patent expiry date: 2032-02-17 | U-1940 |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- DEOXYCHOLIC ACID · UNII 005990WHZZ · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.