Drug facts

Brand

Verzenio (Abemaciclib)

No generic abemaciclib is approved; the latest Verzenio patent or exclusivity in the Orange Book runs to 09/28/2031. 1 staged generic application passed FDA review and waits on patents or exclusivity.

Verzenio was first approved by the FDA on 09/28/2017 under NDA 208716; the application holder is Eli Lilly and Co.

Holder Eli Lilly and CoApplication NDA 208716Approved 09/28/2017

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

1,793days until the latest patent expires

ExclusivityPatent onlyOpen to generics
Today
Approved09/28/2017
Last patent09/28/2031
201820212024202720302033
Latest patent
09/28/2031Verzenio
Orange Book

02Competition

Generics
No generic approved
Orange Book
Staged generics
1 passed FDA review, awaiting market entry
FDA
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Verzenio profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages

04Product

Application holder
Eli Lilly and Co
Orange Book
Application
NDA 208716
Orange Book
First approved
09/28/2017
Orange Book
Dosage forms
tablet
Routes
oral

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.