FDA Orange Book · active-ingredient family
Abemaciclib
Abemaciclib is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VERZENIO · NDA 208716
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VERZENIORLD×4 | ELI LILLY AND CO | NDA 208716 | — | Sep 28, 2017 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7855211 | Sep 28, 2031 | in 5 yr 4 mo | SubstanceProductU-2135 |
Abemaciclib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
