FDA Orange Book · active-ingredient family
Deoxycholic acid
Deoxycholic acid is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KYBELLA · NDA 206333
1
Brand (NDA)
1
Generics (ANDA)
14
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KYBELLARLD | ABBVIE | NDA 206333 | AP | Apr 29, 2015 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEOXYCHOLIC ACID | WILSHIRE PHARMS INC | ANDA 212296 | AP | Apr 02, 2021 |
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7754230 | Dec 10, 2027 | in 1 yr 6 mo | U-1690 |
| 7622130 | Dec 10, 2027 | in 1 yr 6 mo | U-1690 |
| 9949986 | Feb 21, 2028 | in 1 yr 8 mo | U-1940 |
| 9636349 | Feb 21, 2028 | in 1 yr 8 mo | U-1940 |
| 9522155 | Feb 21, 2028 | in 1 yr 8 mo | ProductU-1940 |
| 8546367 | Feb 21, 2028 | in 1 yr 8 mo | ProductU-1690 |
| 8461140 | Feb 21, 2028 | in 1 yr 8 mo | Product |
| 8883770 | Feb 21, 2028 | in 1 yr 8 mo | Product |
| 8242294 | May 16, 2028 | in 1 yr 11 mo | Substance |
| 8653058 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 8367649 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 8101593 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 10500214 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 12161653 | Feb 17, 2032 | in 5 yr 9 mo | U-1940 |
Deoxycholic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
