oxymetazoline hydrochloride; tetracaine hydrochloride · St Renatus · NDA 208032
Kovanaze
Earliest generic entry, as listed
2 Apr 2030
Blocked by patent: US 8580282, US 9308191.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8580282 | drug product, use U-1876 · sets the listed date | 2 Apr 2030 |
| US 9308191 | drug product, use U-1876 · sets the listed date | 2 Apr 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 |
|---|---|---|---|
| 208032 · 001 · RLD | spray, metered, nasal | 0.1MG/SPRAY;6MG/SPRAY | 2 Apr 2030 |