cetirizine hydrochloride · Esteve · NDA 211415
Quzyttir
Earliest generic entry, as listed
28 Feb 2030
Blocked by patent: US 8263581, US 8314083. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8263581 | use U-2635 | 28 Feb 2030 |
| US 8314083 | use U-2634 | 28 Feb 2030 |
| US 8513259 | use U-2636 | 11 Feb 2030 |
| US 9119771 | use U-2635 | 11 Feb 2030 |
| US 9180090 | use U-2635 | 11 Feb 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211415 · 001 · RLD | solution, intravenous | 10MG/ML (10MG/ML) | 28 Feb 2030 |