Orange Book product · Brand (NDA)
AKLIEF
TRIFAROTENE
At a glance
Oct 04, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 04, 2019
6 yr 10 mo ago
Today
Patent 7807708 expires
Listed drug substance patent expiration.
Jul 19, 2031
in 5 yr 2 mo
Patent 9084778 expires
Listed drug product patent expiration.
May 30, 2033
in 7 yr 1 mo
Patent 9498465 expires
Listed drug product patent expiration.
May 30, 2033
in 7 yr 1 mo
Pharmaceutical detail
Active ingredient
TRIFAROTENE
Strength
0.005%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 211527
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 (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7807708 | Jul 19, 2031 | in 5 yr 2 mo | SubstanceProduct |
| 9084778 | May 30, 2033 | in 7 yr 1 mo | ProductU-134 |
| 9498465 | May 30, 2033 | in 7 yr 1 mo | ProductU-1033 |
