Orange Book product · Brand (NDA)
EMBLAVEO
AVIBACTAM SODIUM; AZTREONAM
At a glance
Feb 07, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 07, 2025
1 yr 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 · NP
New product exclusivity (3 years)
Feb 07, 2028
in 1 yr 8 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
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Feb 07, 2033
in 6 yr 9 mo
Pharmaceutical detail
Active ingredient
AVIBACTAM SODIUM; AZTREONAM
Strength
EQ 0.5GM BASE/VIAL;1.5GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 217906
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 (2)
- NPNew product exclusivity (3 years)
Feb 07, 2028
in 1 yr 8 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Feb 07, 2033
in 6 yr 9 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7112592 | Jan 07, 2026 | 5 mo ago | SubstanceProductU-4147 |
| 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 | SubstanceProduct |

