naloxone hydrochloride · Hikma · NDA 212045
Kloxxado
Earliest generic entry, as listed
26 Aug 2034
Blocked by patent: US 10722510, US 10973814, US 11135155, US 11617713, US 11628139, US 11975096, US 12414915.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10722510 | drug product, use U-3110 · sets the listed date | 26 Aug 2034 |
| US 10973814 | drug product, use U-3110 · sets the listed date | 26 Aug 2034 |
| US 11135155 | drug product · sets the listed date | 26 Aug 2034 |
| US 11617713 | drug product, use U-3110 · sets the listed date | 26 Aug 2034 |
| US 11628139 | drug product, use U-3110 · sets the listed date | 26 Aug 2034 |
| US 11975096 | drug product · sets the listed date | 26 Aug 2034 |
| US 12414915 | drug product · sets the listed date | 26 Aug 2034 |
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 |
|---|---|---|---|
| 212045 · 001 · RLD | spray, nasal | 8MG/SPRAY | 26 Aug 2034 |
| 212045 · 002 · RLD · discontinued | spray, nasal | 4MG/SPRAY | open |