# VENCLEXTA — FDA application NDA208573

Informational only - not investment advice.

Application NDA208573 · type NDA · FDA status: approved · original approval 2016-04-11

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 | 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 |

## Orange Book patent and exclusivity listings

- Patent 9174982, product 001; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 001; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 001; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 001; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 002; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 002; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 002; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 002; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 003; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 003; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 003; listed patent expiry date: 2030-05-26.
- Patent 9174982, product 003; listed patent expiry date: 2030-05-26.
- Patent 8546399, product 001; listed patent expiry date: 2031-06-27.
- Patent 8546399, product 002; listed patent expiry date: 2031-06-27.
- Patent 8546399, product 003; listed patent expiry date: 2031-06-27.
- Patent 10730873, product 001; listed patent expiry date: 2031-11-21.
- Patent 10730873, product 002; listed patent expiry date: 2031-11-21.
- Patent 10730873, product 003; listed patent expiry date: 2031-11-21.
- Patent 8722657, product 001; listed patent expiry date: 2032-01-29.
- Patent 8722657, product 002; listed patent expiry date: 2032-01-29.
- Patent 8722657, product 003; listed patent expiry date: 2032-01-29.
- Patent 11369599, product 001; listed patent expiry date: 2032-05-23.
- Patent 11369599, product 002; listed patent expiry date: 2032-05-23.
- Patent 11369599, product 003; listed patent expiry date: 2032-05-23.
- Patent 10993942, product 001; listed patent expiry date: 2033-09-06.
- Patent 10993942, product 002; listed patent expiry date: 2033-09-06.
- Patent 10993942, product 003; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 001; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 001; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 002; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 002; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 003; listed patent expiry date: 2033-09-06.
- Patent 11110087, product 003; listed patent expiry date: 2033-09-06.
- Patent 11413282, product 001; listed patent expiry date: 2033-09-06.
- Patent 11413282, product 002; listed patent expiry date: 2033-09-06.
- Patent 11413282, product 003; listed patent expiry date: 2033-09-06.
- Patent 11590128, product 001; listed patent expiry date: 2033-09-06.
- Patent 11590128, product 002; listed patent expiry date: 2033-09-06.
- Patent 11590128, product 003; listed patent expiry date: 2033-09-06.
- Patent 9539251, product 001; listed patent expiry date: 2033-09-06.
- Patent 9539251, product 002; listed patent expiry date: 2033-09-06.
- Patent 9539251, product 003; listed patent expiry date: 2033-09-06.
- Exclusivity ODE-239, product 001; listed exclusivity date: 2026-05-15.
- Exclusivity ODE-239, product 002; listed exclusivity date: 2026-05-15.
- Exclusivity ODE-239, product 003; listed exclusivity date: 2026-05-15.

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](https://lmmol.com/compound/LQBVNQSMGBZMKD-UHFFFAOYSA-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:NDA208573. FDA data retrieved 2026-08-07.

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