Orange Book product · Brand (NDA)
JUBLIA
EFINACONAZOLE
At a glance
Jun 06, 2014
Approved
Brand (NDA)
Application
AB
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 06, 2014
12 yr 3 mo ago
Patent 7214506 expires
Listed method-of-use patent (U-281) expiration.
Feb 22, 2026
4 mo ago
Today
Patent 10512640 expires
Listed method-of-use patent (U-1969) expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 10828369 expires
Listed drug product patent expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 11213519 expires
Listed method-of-use patent (U-2720) expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 11872218 expires
Listed method-of-use patent (U-1969) expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 9566272 expires
Listed method-of-use patent (U-1969) expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 9877955 expires
Listed method-of-use patent (U-1969) expiration.
Jan 03, 2028
in 1 yr 7 mo
Patent 10105444 expires
Listed drug product patent expiration.
Jul 08, 2030
in 4 yr 1 mo
Patent 8039494 expires
Listed method-of-use patent (U-281) expiration.
Jul 08, 2030
in 4 yr 1 mo
Patent 9861698 expires
Listed drug product patent expiration.
Jul 08, 2030
in 4 yr 1 mo
Patent 8486978 expires
Listed drug product patent expiration.
Oct 24, 2030
in 4 yr 5 mo
Patent 9302009 expires
Listed drug product patent expiration.
Oct 24, 2030
in 4 yr 5 mo
Patent 10342875 expires
Listed drug product patent expiration.
Oct 02, 2034
in 8 yr 5 mo
Patent 10828293 expires
Listed method-of-use patent (U-2720) expiration.
Oct 02, 2034
in 8 yr 5 mo
Patent 10864274 expires
Listed method-of-use patent (U-2720) expiration.
Oct 02, 2034
in 8 yr 5 mo
Patent 11654139 expires
Listed method-of-use patent (U-1969) expiration.
Oct 02, 2034
in 8 yr 5 mo
Patent 9662394 expires
Listed drug product patent expiration.
Oct 02, 2034
in 8 yr 5 mo
Patent 10478601 expires
Listed drug product patent expiration.
Apr 25, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
EFINACONAZOLE
Strength
10%
Dosage form
SOLUTION
Route
TOPICAL
TE code
AB
Application
NDA 203567
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.
- 2026EFINACONAZOLEGeneric (ANDA)
ANDA 212027 · ALEMBIC
- 2022EFINACONAZOLEGeneric (ANDA)
ANDA 212178 · ZYDUS LIFESCIENCES
- 2022EFINACONAZOLEGeneric (ANDA)
ANDA 212169 · LUPIN
- 2021EFINACONAZOLEGeneric (ANDA)
ANDA 211969 · NIVAGEN PHARMS INC
- 2021EFINACONAZOLEGeneric (ANDA)
ANDA 212066 · AUROBINDO PHARMA LTD
- 2020EFINACONAZOLEGeneric (ANDA)
ANDA 211851 · PADAGIS US
- 2020EFINACONAZOLEGeneric (ANDA)
ANDA 211827 · TEVA PHARMS USA
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7214506 | Feb 22, 2026 | 4 mo ago | U-281 |
| 10512640 | Jan 03, 2028 | in 1 yr 7 mo | U-1969 |
| 10828369 | Jan 03, 2028 | in 1 yr 7 mo | Product |
| 11213519 | Jan 03, 2028 | in 1 yr 7 mo | U-2720 |
| 11872218 | Jan 03, 2028 | in 1 yr 7 mo | U-1969 |
| 9566272 | Jan 03, 2028 | in 1 yr 7 mo | U-1969 |
| 9877955 | Jan 03, 2028 | in 1 yr 7 mo | U-1969 |
| 10105444 | Jul 08, 2030 | in 4 yr 1 mo | Product |
| 8039494 | Jul 08, 2030 | in 4 yr 1 mo | U-281 |
| 9861698 | Jul 08, 2030 | in 4 yr 1 mo | Product |
| 8486978 | Oct 24, 2030 | in 4 yr 5 mo | Product |
| 9302009 | Oct 24, 2030 | in 4 yr 5 mo | Product |
| 10342875 | Oct 02, 2034 | in 8 yr 5 mo | ProductU-2720 |
| 10828293 | Oct 02, 2034 | in 8 yr 5 mo | U-2720 |
| 10864274 | Oct 02, 2034 | in 8 yr 5 mo | U-2720 |
| 11654139 | Oct 02, 2034 | in 8 yr 5 mo | U-1969 |
| 9662394 | Oct 02, 2034 | in 8 yr 5 mo | Product |
| 10478601 | Apr 25, 2035 | in 9 yr | ProductU-2721 |
