VENCLEXTA — FDA application NDA208573
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 | VENCLEXTA | VENETOCLAX | TABLET | ORAL | 10MG | Prescription | AB | Yes |
| 002 | VENCLEXTA | VENETOCLAX | TABLET | ORAL | 50MG | Prescription | AB | Yes |
| 003 | VENCLEXTA | VENETOCLAX | TABLET | ORAL | 100MG | Prescription | AB | 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 9174982 | 001 | listed patent expiry date: 2030-05-26 | U-2537 |
| Patent 9174982 | 001 | listed patent expiry date: 2030-05-26 | U-2445 |
| Patent 9174982 | 001 | listed patent expiry date: 2030-05-26 | U-2323 |
| Patent 9174982 | 001 | listed patent expiry date: 2030-05-26 | U-2446 |
| Patent 9174982 | 002 | listed patent expiry date: 2030-05-26 | U-2323 |
| Patent 9174982 | 002 | listed patent expiry date: 2030-05-26 | U-2537 |
| Patent 9174982 | 002 | listed patent expiry date: 2030-05-26 | U-2446 |
| Patent 9174982 | 002 | listed patent expiry date: 2030-05-26 | U-2445 |
| Patent 9174982 | 003 | listed patent expiry date: 2030-05-26 | U-2537 |
| Patent 9174982 | 003 | listed patent expiry date: 2030-05-26 | U-2445 |
| Patent 9174982 | 003 | listed patent expiry date: 2030-05-26 | U-2446 |
| Patent 9174982 | 003 | listed patent expiry date: 2030-05-26 | U-2323 |
| Patent 8546399 | 001 | listed patent expiry date: 2031-06-27 | drug substance, drug product |
| Patent 8546399 | 002 | listed patent expiry date: 2031-06-27 | drug substance, drug product |
| Patent 8546399 | 003 | listed patent expiry date: 2031-06-27 | drug substance, drug product |
| Patent 10730873 | 001 | listed patent expiry date: 2031-11-21 | drug substance |
| Patent 10730873 | 002 | listed patent expiry date: 2031-11-21 | drug substance |
| Patent 10730873 | 003 | listed patent expiry date: 2031-11-21 | drug substance |
| Patent 8722657 | 001 | listed patent expiry date: 2032-01-29 | drug substance |
| Patent 8722657 | 002 | listed patent expiry date: 2032-01-29 | drug substance |
| Patent 8722657 | 003 | listed patent expiry date: 2032-01-29 | drug substance |
| Patent 11369599 | 001 | listed patent expiry date: 2032-05-23 | drug product |
| Patent 11369599 | 002 | listed patent expiry date: 2032-05-23 | drug product |
| Patent 11369599 | 003 | listed patent expiry date: 2032-05-23 | drug product |
| Patent 10993942 | 001 | listed patent expiry date: 2033-09-06 | U-3114 |
| Patent 10993942 | 002 | listed patent expiry date: 2033-09-06 | U-3114 |
| Patent 10993942 | 003 | listed patent expiry date: 2033-09-06 | U-3114 |
| Patent 11110087 | 001 | listed patent expiry date: 2033-09-06 | U-3222 |
| Patent 11110087 | 001 | listed patent expiry date: 2033-09-06 | U-3223 |
| Patent 11110087 | 002 | listed patent expiry date: 2033-09-06 | U-3222 |
| Patent 11110087 | 002 | listed patent expiry date: 2033-09-06 | U-3223 |
| Patent 11110087 | 003 | listed patent expiry date: 2033-09-06 | U-3222 |
| Patent 11110087 | 003 | listed patent expiry date: 2033-09-06 | U-3223 |
| Patent 11413282 | 001 | listed patent expiry date: 2033-09-06 | U-3412 |
| Patent 11413282 | 002 | listed patent expiry date: 2033-09-06 | U-3412 |
| Patent 11413282 | 003 | listed patent expiry date: 2033-09-06 | U-3412 |
| Patent 11590128 | 001 | listed patent expiry date: 2033-09-06 | U-3548 |
| Patent 11590128 | 002 | listed patent expiry date: 2033-09-06 | U-3548 |
| Patent 11590128 | 003 | listed patent expiry date: 2033-09-06 | U-3548 |
| Patent 9539251 | 001 | listed patent expiry date: 2033-09-06 | U-2538 |
| Patent 9539251 | 002 | listed patent expiry date: 2033-09-06 | U-2538 |
| Patent 9539251 | 003 | listed patent expiry date: 2033-09-06 | U-2538 |
| Exclusivity ODE-239 | 001 | listed exclusivity date: 2026-05-15 | FDA code as listed |
| Exclusivity ODE-239 | 002 | listed exclusivity date: 2026-05-15 | FDA code as listed |
| Exclusivity ODE-239 | 003 | listed exclusivity date: 2026-05-15 | 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
- VENETOCLAX · UNII N54AIC43PW · lmmol compound LQBVNQSMGBZMKD-UHFFFAOYSA-N · CHEMBL3137309
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.