Orange Book product · Brand (NDA)
BYFAVO
REMIMAZOLAM BESYLATE
At a glance
Oct 06, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 2020
5 yr 9 mo ago
Today
Patent 10472365 expires
Listed method-of-use patent (U-2968) expiration.
Jul 10, 2027
in 1 yr 1 mo
Patent 10961250 expires
Listed drug product patent expiration.
Jul 10, 2027
in 1 yr 1 mo
Patent 9777007 expires
Listed drug product patent expiration.
Jul 10, 2027
in 1 yr 1 mo
Patent 9914738 expires
Listed drug product patent expiration.
Jul 10, 2027
in 1 yr 1 mo
Patent 10052334 expires
Listed method-of-use patent (U-2968) expiration.
Nov 07, 2031
in 5 yr 6 mo
Patent 10195210 expires
Listed method-of-use patent (U-2968) expiration.
Nov 07, 2031
in 5 yr 6 mo
Patent 10342800 expires
Listed method-of-use patent (U-2968) expiration.
Nov 07, 2031
in 5 yr 6 mo
Patent 10722522 expires
Listed method-of-use patent (U-2968) expiration.
Nov 07, 2031
in 5 yr 6 mo
Patent 9737547 expires
Listed method-of-use patent (U-2968) expiration.
Nov 07, 2031
in 5 yr 6 mo
Patent 9561236 expires
Listed method-of-use patent (U-2968) expiration.
Apr 30, 2033
in 7 yr
Patent 9827251 expires
Listed method-of-use patent (U-2968) expiration.
Jan 13, 2034
in 7 yr 8 mo
Pharmaceutical detail
Active ingredient
REMIMAZOLAM BESYLATE
Strength
EQ 20MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 212295
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 (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10472365 | Jul 10, 2027 | in 1 yr 1 mo | U-2968 |
| 10961250 | Jul 10, 2027 | in 1 yr 1 mo | ProductU-2968 |
| 9777007 | Jul 10, 2027 | in 1 yr 1 mo | Product |
| 9914738 | Jul 10, 2027 | in 1 yr 1 mo | Product |
| 10052334 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 10195210 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 10342800 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 10722522 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 9737547 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 9561236 | Apr 30, 2033 | in 7 yr | U-2968 |
| 9827251 | Jan 13, 2034 | in 7 yr 8 mo | U-2968 |
