Orange Book product · Brand (NDA)
BESIVANCE
BESIFLOXACIN HYDROCHLORIDE
At a glance
May 28, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 2009
17 yr 4 mo ago
Today
Patent 8937062 expires
Listed method-of-use patent (U-80) expiration.
Nov 13, 2029
in 3 yr 5 mo
Patent 8604020 expires
Listed drug product patent expiration.
Mar 12, 2030
in 3 yr 9 mo
Patent 8415342 expires
Listed method-of-use patent (U-80) expiration.
Nov 07, 2030
in 4 yr 5 mo
Patent 8481526 expires
Listed drug substance patent expiration.
Jan 09, 2031
in 4 yr 8 mo
Pharmaceutical detail
Active ingredient
BESIFLOXACIN HYDROCHLORIDE
Strength
EQ 0.6% BASE
Dosage form
SUSPENSION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 022308
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 |
|---|---|---|---|
| 8937062 | Nov 13, 2029 | in 3 yr 5 mo | U-80 |
| 8604020 | Mar 12, 2030 | in 3 yr 9 mo | Product |
| 8415342 | Nov 07, 2030 | in 4 yr 5 mo | U-80 |
| 8481526 | Jan 09, 2031 | in 4 yr 8 mo | Substance |
