betrixaban · Portola Pharms Inc · NDA 208383
Bevyxxa
Earliest generic entry, as listed · earliest of 2 marketed strengths
29 Mar 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8404724.
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8404724 | drug product, use U-2034 · sets the listed date | 29 Mar 2031 |
| US 8987463 | drug product | 28 Dec 2030 |
| US 8557852 | use U-1167, U-2030 | 8 Sep 2028 |
| US 8557852 listing row | use U-1167 | 8 Sep 2028 |
| US 8557852 listing row | use U-2030 | 8 Sep 2028 |
| US 7598276 | drug substance | 8 Nov 2026 |
| US 9555023 | use U-1502 | 7 Nov 2026 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208383 · 001 · RLD · discontinued | capsule, oral | 40MG | 29 Mar 2031 |
| 208383 · 002 · RLD · discontinued | capsule, oral | 80MG | 29 Mar 2031 |