# VERZENIO — FDA application NDA208716

Informational only - not investment advice.

Application NDA208716 · type NDA · FDA status: approved · original approval 2017-09-28

Listed sponsor: ELI LILLY AND CO · [LLY company profile](/company/LLY/) · 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 | VERZENIO | ABEMACICLIB | TABLET | ORAL | 50MG | Prescription | not listed | Yes |
| 002 | VERZENIO | ABEMACICLIB | TABLET | ORAL | 100MG | Prescription | not listed | Yes |
| 003 | VERZENIO | ABEMACICLIB | TABLET | ORAL | 150MG | Prescription | not listed | Yes |
| 004 | VERZENIO | ABEMACICLIB | TABLET | ORAL | 200MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7855211, product 001; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 001; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 001; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 001; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 002; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 002; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 002; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 002; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 003; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 003; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 003; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 003; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 004; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 004; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 004; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 004; listed patent expiry date: 2031-09-28.
- Patent 7855211, product 004; listed patent expiry date: 2031-09-28.

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

- ABEMACICLIB · UNII 60UAB198HK · [lmmol compound UZWDCWONPYILKI-UHFFFAOYSA-N](https://lmmol.com/compound/UZWDCWONPYILKI-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/LLY/)
- [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:NDA208716. FDA data retrieved 2026-08-07.

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