zolpidem tartrate · Purdue Pharma · NDA 022328
Intermezzo
Earliest generic entry, as listed · earliest of 2 marketed strengths
20 Aug 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8242131. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8242131 | use U-1266 · sets the listed date | 20 Aug 2029 |
| US 7658945 | drug product, use U-1194 | 15 Apr 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022328 · 001 · RLD · discontinued | tablet, sublingual | 1.75MG | 20 Aug 2029 |
| 022328 · 002 · RLD · discontinued | tablet, sublingual | 3.5MG | 20 Aug 2029 |