plazomicin sulfate · Cipla Usa · NDA 210303
Zemdri
Earliest generic entry, as listed
25 Jun 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8383596.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8383596 | substance, use U-2328 | 25 Jun 2032 |
| US 8822424 | product | 21 Nov 2028 |
| US 9266919 | use U-2328 | 21 Nov 2028 |
| US 9688711 | substance, use U-2328 | 21 Nov 2028 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 25 Jun 2028 |
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 |
|---|---|---|---|
| 210303 · 001 · RLD · discontinued | solution, intravenous | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | 25 Jun 2032 |
Expired or delisted (1)
- NCE · 25 Jun 2023