FDA Orange Book
Is there a generic for Emblaveo?
Emblaveo contains aztreonam and avibactam. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Emblaveo (aztreonam and avibactam). The Orange Book shows its last listed patent expires June 15, 2032 and its last listed exclusivity ends February 7, 2033.
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Emblaveo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 0.5GM BASE/VIAL;1.5GM/VIAL | Marketed (Rx) | None | 0 | None |
NDA 217906, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Emblaveo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7112592 | January 7, 2026 | Drug substance, Drug product | U-4147 | 217906 |
| 7612087 | November 12, 2026 | Drug product | None | 217906 |
| 8835455 | October 8, 2030 | Drug product | None | 217906 |
| 8471025 | August 12, 2031 | Drug substance | None | 217906 |
| 8969566 | June 15, 2032 | Drug substance | None | 217906 |
| 9695122 | June 15, 2032 | Drug substance, Drug product | None | 217906 |
| 9284314 | June 15, 2032 | Drug substance | None | 217906 |
Emblaveo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | February 7, 2028 | 217906 |
| GAIN | Generating Antibiotic Incentives Now | February 7, 2033 | 217906 |
Emblaveo NDC codes
Questions
Is there a generic for Emblaveo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Emblaveo (aztreonam and avibactam). The Orange Book shows its last listed patent expires June 15, 2032 and its last listed exclusivity ends February 7, 2033.
What is the generic name for Emblaveo?
The active ingredient in Emblaveo is aztreonam and avibactam, per the FDA Orange Book.
When does the Emblaveo patent expire?
The last patent listed for Emblaveo in the Orange Book expires June 15, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.