zolpidem tartrate · Aytu · NDA 022196
Zolpimist
Earliest generic entry, as listed
7 Aug 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8236285.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8236285 | substance, product, use U-70 | 7 Aug 2032 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022196 · 001 · RLD · discontinued | spray, metered, oral | 5MG/SPRAY | 7 Aug 2032 |