AVYCAZ — FDA application NDA206494
Listed sponsor: ABBVIE · ABBV company profile · 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 | AVYCAZ | AVIBACTAM SODIUM; CEFTAZIDIME | POWDER | INTRAVENOUS | EQ 0.5GM BASE;2GM/VIAL | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 7112592 | 001 | listed patent expiry date: 2026-01-07 | drug substance, drug product, U-2508 |
| Patent 7112592 | 001 | listed patent expiry date: 2026-01-07 | drug substance, drug product, U-2244 |
| Patent 7112592 | 001 | listed patent expiry date: 2026-01-07 | drug substance, drug product, U-282 |
| Patent 7112592 | 001 | listed patent expiry date: 2026-01-07 | drug substance, drug product, U-3818 |
| Patent 7612087 | 001 | listed patent expiry date: 2026-11-12 | drug product |
| Patent 8835455 | 001 | listed patent expiry date: 2030-10-08 | drug product |
| Patent 8471025 | 001 | listed patent expiry date: 2031-08-12 | drug substance |
| Patent 8969566 | 001 | listed patent expiry date: 2032-06-15 | drug substance |
| Patent 9284314 | 001 | listed patent expiry date: 2032-06-15 | drug substance |
| Patent 9695122 | 001 | listed patent expiry date: 2032-06-15 | drug substance |
| Exclusivity NPP | 001 | listed exclusivity date: 2027-01-26 | FDA code as listed |
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 SODIUM · UNII 9V824P8TAI · lmmol compound RTCIKUMODPANKX-JBUOLDKXSA-M · CHEMBL2107817
- CEFTAZIDIME · UNII 9M416Z9QNR · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.