Orange Book product · Brand (NDA)
XTORO
FINAFLOXACIN
At a glance
Dec 17, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2014
11 yr 8 mo ago
Today
Patent 9119859 expires
Listed method-of-use patent (U-1679) expiration.
Jul 02, 2030
in 4 yr 1 mo
Patent 9993483 expires
Listed drug product patent expiration.
Jul 02, 2030
in 4 yr 1 mo
Patent 8536167 expires
Listed method-of-use patent (U-1679) expiration.
Aug 08, 2031
in 5 yr 3 mo
Patent 9504691 expires
Listed drug product patent expiration.
Nov 21, 2033
in 7 yr 6 mo
Pharmaceutical detail
Active ingredient
FINAFLOXACIN
Strength
0.3%
Dosage form
SUSPENSION/DROPS
Route
OTIC
TE code
Not listed
Application
NDA 206307
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 (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9119859 | Jul 02, 2030 | in 4 yr 1 mo | U-1679 |
| 9993483 | Jul 02, 2030 | in 4 yr 1 mo | Product |
| 8536167 | Aug 08, 2031 | in 5 yr 3 mo | U-1679 |
| 9504691 | Nov 21, 2033 | in 7 yr 6 mo | ProductU-1679 |
