# EMBLAVEO — FDA application NDA217906

Informational only - not investment advice.

Application NDA217906 · type NDA · FDA status: approved · original approval 2025-02-07

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | EMBLAVEO | AVIBACTAM SODIUM; AZTREONAM | POWDER | INTRAVENOUS | EQ 0.5GM BASE/VIAL;1.5GM/VIAL | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7112592, product 001; listed patent expiry date: 2026-01-07.
- Patent 7612087, product 001; listed patent expiry date: 2026-11-12.
- Patent 8835455, product 001; listed patent expiry date: 2030-10-08.
- Patent 8471025, product 001; listed patent expiry date: 2031-08-12.
- Patent 8969566, product 001; listed patent expiry date: 2032-06-15.
- Patent 9284314, product 001; listed patent expiry date: 2032-06-15.
- Patent 9695122, product 001; listed patent expiry date: 2032-06-15.
- Exclusivity NP, product 001; listed exclusivity date: 2028-02-07.
- Exclusivity GAIN, product 001; listed exclusivity date: 2033-02-07.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- AVIBACTAM · UNII 7352665165 · no lmmol compound match
- AZTREONAM · UNII G2B4VE5GH8 · [lmmol compound WZPBZJONDBGPKJ-VEHQQRBSSA-N](https://lmmol.com/compound/WZPBZJONDBGPKJ-VEHQQRBSSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217906. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.