acetaminophen; benzhydrocodone hydrochloride · Zevra Therap · NDA 208653
Apadaz
Earliest generic entry, as listed · earliest of 3 marketed strengths
22 Feb 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8461137.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8461137 | drug substance, drug product · sets the listed date | 22 Feb 2031 |
| US 8748413 | drug substance, drug product | 1 Jul 2030 |
| US 8828978 | drug product | 1 Jul 2030 |
| US 9132125 | drug substance, drug product, use U-2249 | 1 Jul 2030 |
| US 9549923 | drug substance, drug product | 1 Jul 2030 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208653 · 001 · RLD · discontinued | tablet, oral | 325MG;EQ 6.12MG BASE | 22 Feb 2031 |
| 208653 · 002 · RLD · discontinued | tablet, oral | 325MG;EQ 4.08MG BASE | 22 Feb 2031 |
| 208653 · 003 · RLD · discontinued | tablet, oral | 325MG;EQ 8.16MG BASE | 22 Feb 2031 |