Orange Book product · Brand (NDA)
BEVYXXA
BETRIXABAN
At a glance
Jun 23, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2017
9 yr 1 mo ago
Today
Patent 9555023 expires
Listed method-of-use patent (U-1502) expiration.
Nov 07, 2026
in 5 mo
Patent 7598276 expires
Listed drug substance patent expiration.
Nov 08, 2026
in 5 mo
Patent 8557852 expires
Listed method-of-use patent (U-1167) expiration.
Sep 08, 2028
in 2 yr 3 mo
Patent 8557852 expires
Listed method-of-use patent (U-2030) expiration.
Sep 08, 2028
in 2 yr 3 mo
Patent 8987463 expires
Listed drug product patent expiration.
Dec 28, 2030
in 4 yr 7 mo
Patent 8404724 expires
Listed drug product patent expiration.
Mar 29, 2031
in 4 yr 10 mo
Pharmaceutical detail
Active ingredient
BETRIXABAN
Strength
80MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 208383
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9555023 | Nov 07, 2026 | in 5 mo | U-1502 |
| 7598276 | Nov 08, 2026 | in 5 mo | Substance |
| 8557852 | Sep 08, 2028 | in 2 yr 3 mo | U-1167 |
| 8557852 | Sep 08, 2028 | in 2 yr 3 mo | U-2030 |
| 8987463 | Dec 28, 2030 | in 4 yr 7 mo | Product |
| 8404724 | Mar 29, 2031 | in 4 yr 10 mo | ProductU-2034 |
