hydrocodone bitartrate · Teva Branded Pharm · NDA 207975
Vantrela Er
Earliest generic entry, as listed · earliest of 5 marketed strengths
31 Jul 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8445018.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8445018 | drug product · sets the listed date | 31 Jul 2029 |
| US 9216176 | drug product | 13 Sep 2027 |
| US 9572803 | drug product | 13 Sep 2027 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207975 · 001 · RLD · discontinued | tablet, extended release, oral | 15MG | 31 Jul 2029 |
| 207975 · 002 · RLD · discontinued | tablet, extended release, oral | 30MG | 31 Jul 2029 |
| 207975 · 003 · RLD · discontinued | tablet, extended release, oral | 45MG | 31 Jul 2029 |
| 207975 · 004 · RLD · discontinued | tablet, extended release, oral | 60MG | 31 Jul 2029 |
| 207975 · 005 · RLD · discontinued | tablet, extended release, oral | 90MG | 31 Jul 2029 |