Orange Book product · Brand (NDA)
KYBELLA
DEOXYCHOLIC ACID
At a glance
Apr 29, 2015
Approved
Brand (NDA)
Application
AP
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 29, 2015
11 yr 4 mo ago
Today
Patent 7622130 expires
Listed method-of-use patent (U-1690) expiration.
Dec 10, 2027
in 1 yr 6 mo
Patent 7754230 expires
Listed method-of-use patent (U-1690) expiration.
Dec 10, 2027
in 1 yr 6 mo
Patent 8461140 expires
Listed drug product patent expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 8546367 expires
Listed drug product patent expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 8883770 expires
Listed drug product patent expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 9522155 expires
Listed drug product patent expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 9636349 expires
Listed method-of-use patent (U-1940) expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 9949986 expires
Listed method-of-use patent (U-1940) expiration.
Feb 21, 2028
in 1 yr 8 mo
Patent 8242294 expires
Listed drug substance patent expiration.
May 16, 2028
in 1 yr 11 mo
Patent 10500214 expires
Listed drug product patent expiration.
Mar 02, 2030
in 3 yr 9 mo
Patent 8101593 expires
Listed drug product patent expiration.
Mar 02, 2030
in 3 yr 9 mo
Patent 8367649 expires
Listed drug product patent expiration.
Mar 02, 2030
in 3 yr 9 mo
Patent 8653058 expires
Listed drug product patent expiration.
Mar 02, 2030
in 3 yr 9 mo
Patent 12161653 expires
Listed method-of-use patent (U-1940) expiration.
Feb 17, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
DEOXYCHOLIC ACID
Strength
20MG/2ML (10MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
AP
Application
NDA 206333
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7622130 | Dec 10, 2027 | in 1 yr 6 mo | U-1690 |
| 7754230 | Dec 10, 2027 | in 1 yr 6 mo | U-1690 |
| 8461140 | Feb 21, 2028 | in 1 yr 8 mo | Product |
| 8546367 | Feb 21, 2028 | in 1 yr 8 mo | ProductU-1690 |
| 8883770 | Feb 21, 2028 | in 1 yr 8 mo | Product |
| 9522155 | Feb 21, 2028 | in 1 yr 8 mo | ProductU-1940 |
| 9636349 | Feb 21, 2028 | in 1 yr 8 mo | U-1940 |
| 9949986 | Feb 21, 2028 | in 1 yr 8 mo | U-1940 |
| 8242294 | May 16, 2028 | in 1 yr 11 mo | Substance |
| 10500214 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 8101593 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 8367649 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 8653058 | Mar 02, 2030 | in 3 yr 9 mo | Product |
| 12161653 | Feb 17, 2032 | in 5 yr 9 mo | U-1940 |
