FDA Orange Book · active-ingredient family
Avibactam sodium; aztreonam
Avibactam sodium; aztreonam is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EMBLAVEO · NDA 217906
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
2
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EMBLAVEORLD | ABBVIE | NDA 217906 | — | Feb 07, 2025 |
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 |
| 9695122 | Jun 15, 2032 | in 6 yr 1 mo | SubstanceProduct |
| 9284314 | Jun 15, 2032 | in 6 yr 1 mo | Substance |
Avibactam sodium; aztreonam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
