FDA Orange Book
Is there a generic for Verzenio?
Verzenio contains abemaciclib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Verzenio (abemaciclib). The Orange Book shows its last listed patent expires September 28, 2031.
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Verzenio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 208716, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Verzenio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7855211 | September 28, 2031 | Drug substance, Drug product | U-2135 | 208716 |
| 7855211 | September 28, 2031 | Drug substance, Drug product | U-3546 | 208716 |
| 7855211 | September 28, 2031 | Drug substance, Drug product | U-3265 | 208716 |
| 7855211 | September 28, 2031 | Drug substance, Drug product | U-3242 | 208716 |
| 7855211 | September 28, 2031 | Drug substance, Drug product | U-1981 | 208716 |
Verzenio NDC codes
Questions
Is there a generic for Verzenio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Verzenio (abemaciclib). The Orange Book shows its last listed patent expires September 28, 2031.
What is the generic name for Verzenio?
The active ingredient in Verzenio is abemaciclib, per the FDA Orange Book.
When does the Verzenio patent expire?
The last patent listed for Verzenio in the Orange Book expires September 28, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.