Orange Book product · Brand (NDA)
EPSOLAY
BENZOYL PEROXIDE
At a glance
Apr 22, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
14
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 2022
4 yr 3 mo ago
Today
Patent 12156946 expires
Listed drug product patent expiration.
Feb 03, 2028
in 1 yr 8 mo
Patent 12350382 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 9687465 expires
Listed drug product patent expiration.
Nov 27, 2032
in 6 yr 6 mo
Patent 10933046 expires
Listed drug product patent expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 10945987 expires
Listed method-of-use patent (U-3356) expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 11541026 expires
Listed method-of-use patent (U-3356) expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 11865100 expires
Listed method-of-use patent (U-3357) expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 11877997 expires
Listed method-of-use patent (U-3356) expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 11986456 expires
Listed method-of-use patent (U-3947) expiration.
Feb 19, 2040
in 13 yr 10 mo
Patent 11426378 expires
Listed method-of-use patent (U-3356) expiration.
Aug 18, 2040
in 14 yr 4 mo
Patent 11628155 expires
Listed method-of-use patent (U-3356) expiration.
Dec 27, 2040
in 14 yr 9 mo
Patent 12295935 expires
Listed method-of-use patent (U-3356) expiration.
Dec 27, 2040
in 14 yr 9 mo
Patent 12257348 expires
Listed drug product patent expiration.
May 23, 2041
in 15 yr 2 mo
Pharmaceutical detail
Active ingredient
BENZOYL PEROXIDE
Strength
5%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 214510
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 |
|---|---|---|---|
| 12156946 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 12350382 | Feb 03, 2028 | in 1 yr 8 mo | Product |
| 9868103 | Aug 08, 2028 | in 2 yr 2 mo | ProductU-3356 |
| 9687465 | Nov 27, 2032 | in 6 yr 6 mo | ProductU-3356 |
| 10933046 | Feb 19, 2040 | in 13 yr 10 mo | ProductU-3357 |
| 10945987 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 11541026 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 11865100 | Feb 19, 2040 | in 13 yr 10 mo | U-3357 |
| 11877997 | Feb 19, 2040 | in 13 yr 10 mo | U-3356 |
| 11986456 | Feb 19, 2040 | in 13 yr 10 mo | U-3947 |
| 11426378 | Aug 18, 2040 | in 14 yr 4 mo | U-3356 |
| 11628155 | Dec 27, 2040 | in 14 yr 9 mo | U-3356 |
| 12295935 | Dec 27, 2040 | in 14 yr 9 mo | U-3356 |
| 12257348 | May 23, 2041 | in 15 yr 2 mo | ProductU-3947 |
