cetirizine hydrochloride · Harrow Eye · NDA 208694
Zerviate
Earliest generic entry, as listed
9 Jan 2033
Blocked by patent: US 9254286 (pediatric extension).
Listed patents · 4 unexpired
6 Orange Book listing rows for 4 patents, including 2 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9254286 | drug product | 9 Jan 2033 |
| US 9254286 listing row | drug product | 9 Jul 2032 |
| US 9254286 listing row | pediatric extension · sets the listed date | 9 Jan 2033 |
| US 8829005 | use U-1680 | 15 Sep 2030 |
| US 8829005 listing row | use U-1680 | 15 Mar 2030 |
| US 8829005 listing row | pediatric extension | 15 Sep 2030 |
| US 9750684 | drug product | 15 Mar 2030 |
| US 9993471 | use U-1680 | 15 Mar 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 |
|---|---|---|---|
| 208694 · 001 · RLD | solution/drops, ophthalmic | EQ 0.24% BASE | 9 Jan 2033 |