Orange Book product · Brand (NDA)
TWYNEO
BENZOYL PEROXIDE; TRETINOIN
At a glance
Jul 26, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2021
5 yr ago
Today
Patent 12156946 expires
Listed drug product patent expiration.
Feb 03, 2028
in 1 yr 8 mo
Patent 8617580 expires
Listed drug product patent expiration.
Feb 03, 2028
in 1 yr 8 mo
Patent 9868103 expires
Listed drug product patent expiration.
Aug 08, 2028
in 2 yr 2 mo
Patent 10653899 expires
Listed drug product patent expiration.
Dec 30, 2030
in 4 yr 7 mo
Patent 11071878 expires
Listed drug product patent expiration.
Dec 30, 2030
in 4 yr 7 mo
Patent 12070629 expires
Listed drug product patent expiration.
Dec 30, 2030
in 4 yr 7 mo
Patent 12053546 expires
Listed drug product patent expiration.
Jun 29, 2032
in 6 yr 1 mo
Patent 10420743 expires
Listed method-of-use patent (U-3194) expiration.
Jul 12, 2038
in 12 yr 3 mo
Patent 12357602 expires
Listed drug product patent expiration.
Jul 12, 2038
in 12 yr 3 mo
Patent 12295935 expires
Listed method-of-use patent (U-3987) expiration.
Dec 27, 2040
in 14 yr 9 mo
Patent 12133919 expires
Listed drug product patent expiration.
May 23, 2041
in 15 yr 2 mo
Patent 12257348 expires
Listed drug product patent expiration.
May 23, 2041
in 15 yr 2 mo
Patent 12491163 expires
Listed drug product patent expiration.
May 23, 2041
in 15 yr 2 mo
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE; TRETINOIN
Strength
3%;0.1%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 214902
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 (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12156946 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 8617580 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 9868103 | Aug 08, 2028 | in 2 yr 2 mo | ProductU-3194 |
| 10653899 | Dec 30, 2030 | in 4 yr 7 mo | ProductU-3194 |
| 11071878 | Dec 30, 2030 | in 4 yr 7 mo | Product |
| 12070629 | Dec 30, 2030 | in 4 yr 7 mo | ProductU-3987 |
| 12053546 | Jun 29, 2032 | in 6 yr 1 mo | Product |
| 10420743 | Jul 12, 2038 | in 12 yr 3 mo | U-3194 |
| 12357602 | Jul 12, 2038 | in 12 yr 3 mo | ProductU-3987 |
| 12295935 | Dec 27, 2040 | in 14 yr 9 mo | U-3987 |
| 12133919 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |
| 12257348 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |
| 12491163 | May 23, 2041 | in 15 yr 2 mo | ProductU-3987 |

