ondansetron · Aquestive · NDA 022524
Zuplenz
Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Jul 2030
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9095577.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9095577 | drug product · sets the listed date | 13 Jul 2030 |
| US 8580830 | drug product | 23 Nov 2029 |
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 |
|---|---|---|---|
| 022524 · 001 · RLD · discontinued | film, oral | 4MG | 13 Jul 2030 |
| 022524 · 002 · RLD · discontinued | film, oral | 8MG | 13 Jul 2030 |