Orange Book product · Brand (NDA)
ZEMDRI
PLAZOMICIN SULFATE
At a glance
Jun 25, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 25, 2018
8 yr 1 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 25, 2023
3 yr ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Jun 25, 2028
in 2 yr 1 mo
Patent 8822424 expires
Listed drug product patent expiration.
Nov 21, 2028
in 2 yr 6 mo
Patent 9266919 expires
Listed method-of-use patent (U-2328) expiration.
Nov 21, 2028
in 2 yr 6 mo
Patent 9688711 expires
Listed drug substance patent expiration.
Nov 21, 2028
in 2 yr 6 mo
Patent 8383596 expires
Listed drug substance patent expiration.
Jun 25, 2032
in 6 yr 1 mo
Pharmaceutical detail
Active ingredient
PLAZOMICIN SULFATE
Strength
EQ 500MG BASE/10ML (EQ 50MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 210303
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Jun 25, 2023
3 yr ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Jun 25, 2028
in 2 yr 1 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8822424 | Nov 21, 2028 | in 2 yr 6 mo | Product |
| 9266919 | Nov 21, 2028 | in 2 yr 6 mo | U-2328 |
| 9688711 | Nov 21, 2028 | in 2 yr 6 mo | SubstanceU-2328 |
| 8383596 | Jun 25, 2032 | in 6 yr 1 mo | SubstanceU-2328 |

