FDA Orange Book · active-ingredient family
Betrixaban
Betrixaban is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BEVYXXA · NDA 208383
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BEVYXXARLD×2 | PORTOLA PHARMS INC | NDA 208383 | — | Jun 23, 2017 |
Listed patents (5)
| 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 |
| 8987463 | Dec 28, 2030 | in 4 yr 7 mo | Product |
| 8404724 | Mar 29, 2031 | in 4 yr 10 mo | ProductU-2034 |
Betrixaban — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
