Orange Book product · Brand (NDA)
AVYCAZ
AVIBACTAM SODIUM; CEFTAZIDIME
At a glance
Feb 25, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 25, 2015
11 yr 6 mo ago
Patent 7112592 expires
Listed drug substance patent expiration.
Jan 07, 2026
5 mo ago
Patent 7112592 expires
Listed drug substance patent expiration.
Jan 07, 2026
5 mo ago
Patent 7112592 expires
Listed drug substance patent expiration.
Jan 07, 2026
5 mo ago
Patent 7112592 expires
Listed drug substance patent expiration.
Jan 07, 2026
5 mo ago
Today
Patent 7612087 expires
Listed drug product patent expiration.
Nov 12, 2026
in 5 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Jan 26, 2027
in 7 mo
Patent 8835455 expires
Listed drug product patent expiration.
Oct 08, 2030
in 4 yr 4 mo
Patent 8471025 expires
Listed drug substance patent expiration.
Aug 12, 2031
in 5 yr 3 mo
Patent 8969566 expires
Listed drug substance patent expiration.
Jun 15, 2032
in 6 yr 1 mo
Patent 9284314 expires
Listed drug substance patent expiration.
Jun 15, 2032
in 6 yr 1 mo
Patent 9695122 expires
Listed drug substance patent expiration.
Jun 15, 2032
in 6 yr 1 mo
Pharmaceutical detail
Active ingredient
AVIBACTAM SODIUM; CEFTAZIDIME
Strength
EQ 0.5GM BASE;2GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 206494
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (1)
- NPPNew patient population exclusivity (3 years)
Jan 26, 2027
in 7 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7112592 | Jan 07, 2026 | 5 mo ago | SubstanceProductU-2508 |
| 7112592 | Jan 07, 2026 | 5 mo ago | SubstanceProductU-2244 |
| 7112592 | Jan 07, 2026 | 5 mo ago | SubstanceProductU-282 |
| 7112592 | Jan 07, 2026 | 5 mo ago | SubstanceProductU-3818 |
| 7612087 | Nov 12, 2026 | in 5 mo | Product |
| 8835455 | Oct 08, 2030 | in 4 yr 4 mo | Product |
| 8471025 | Aug 12, 2031 | in 5 yr 3 mo | Substance |
| 8969566 | Jun 15, 2032 | in 6 yr 1 mo | Substance |
| 9284314 | Jun 15, 2032 | in 6 yr 1 mo | Substance |
| 9695122 | Jun 15, 2032 | in 6 yr 1 mo | Substance |

