naloxone hydrochloride · Zmi Pharma · NDA 212854
Zimhi
Earliest generic entry, as listed
14 Jun 2041
Blocked by patent: US 11571518.
Listed patents · 2 unexpired
4 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11571518 | drug product, use U-3515, U-3516, U-3517 | 14 Jun 2041 |
| US 11571518 listing row | drug product, use U-3515 · sets the listed date | 14 Jun 2041 |
| US 11571518 listing row | drug product, use U-3516 · sets the listed date | 14 Jun 2041 |
| US 11571518 listing row | drug product, use U-3517 · sets the listed date | 14 Jun 2041 |
| US 11027072 | drug product | 24 May 2039 |
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 |
|---|---|---|---|
| 212854 · 001 · RLD | solution, intramuscular, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | 14 Jun 2041 |