Orange Book product · Brand (NDA)
DUOBRII
HALOBETASOL PROPIONATE; TAZAROTENE
At a glance
Apr 25, 2019
Approved
Brand (NDA)
Application
AB
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2019
7 yr 3 mo ago
Today
Patent 10478502 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11839656 expires
Listed method-of-use patent (U-2625) expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11957753 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 11986527 expires
Listed method-of-use patent (U-2625) expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 12076403 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 8809307 expires
Listed drug product patent expiration.
Nov 02, 2031
in 5 yr 5 mo
Patent 10251895 expires
Listed drug product patent expiration.
Jun 06, 2036
in 10 yr 1 mo
Patent 10426787 expires
Listed method-of-use patent (U-2625) expiration.
Jun 06, 2036
in 10 yr 1 mo
Patent 11648256 expires
Listed drug product patent expiration.
Jun 06, 2036
in 10 yr 1 mo
Patent 11679115 expires
Listed drug product patent expiration.
Jun 06, 2036
in 10 yr 1 mo
Pharmaceutical detail
Active ingredient
HALOBETASOL PROPIONATE; TAZAROTENE
Strength
0.01%;0.045%
Dosage form
LOTION
Route
TOPICAL
TE code
AB
Application
NDA 209354
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 (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10478502 | Nov 02, 2031 | in 5 yr 5 mo | ProductU-2625 |
| 11839656 | Nov 02, 2031 | in 5 yr 5 mo | U-2625 |
| 11957753 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 11986527 | Nov 02, 2031 | in 5 yr 5 mo | U-2625 |
| 12076403 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 8809307 | Nov 02, 2031 | in 5 yr 5 mo | Product |
| 10251895 | Jun 06, 2036 | in 10 yr 1 mo | Product |
| 10426787 | Jun 06, 2036 | in 10 yr 1 mo | U-2625 |
| 11648256 | Jun 06, 2036 | in 10 yr 1 mo | ProductU-2625 |
| 11679115 | Jun 06, 2036 | in 10 yr 1 mo | ProductU-2625 |
