FDA Orange Book · active-ingredient family
Remimazolam besylate
Remimazolam besylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BYFAVO · NDA 212295
1
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BYFAVORLD | ACACIA | NDA 212295 | — | Oct 06, 2020 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10961250 | Jul 10, 2027 | in 1 yr 1 mo | ProductU-2968 |
| 10472365 | Jul 10, 2027 | in 1 yr 1 mo | U-2968 |
| 9777007 | Jul 10, 2027 | in 1 yr 1 mo | Product |
| 9914738 | Jul 10, 2027 | in 1 yr 1 mo | Product |
| 9737547 | Nov 07, 2031 | in 5 yr 6 mo | U-2968 |
| 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 |
| 9561236 | Apr 30, 2033 | in 7 yr | U-2968 |
| 9827251 | Jan 13, 2034 | in 7 yr 8 mo | U-2968 |
Remimazolam besylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
