quazepam · Galt Pharms · NDA 018708
Doral
Earliest generic entry, as listed
3 Jun 2028
Blocked by patent: US 7608616. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7608616 | use U-1012 · sets the listed date | 3 Jun 2028 |
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 |
|---|---|---|---|
| 018708 · 001 · RLD | tablet, oral | 15MG | 3 Jun 2028 |
| 018708 · 003 · discontinued | tablet, oral | 7.5MG | 3 Jun 2028 |