Drug facts
BrandVraylar (Cariprazine)
No generic cariprazine has an active Orange Book listing (a generic was first approved 09/09/2022); the latest Vraylar patent or exclusivity in the Orange Book runs to 03/17/2030.
Vraylar was first approved by the FDA on 09/17/2015 under NDA 204370; the application holder is Abbvie Inc.
The latest NADAC for VRAYLAR 4.5 MG CAPSULE is $50.78 per unit (as of 10/28/2026).
Holder Abbvie IncApplication NDA 204370Approved 09/17/2015
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.
1,233days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved09/17/2015
Exclusivity ends06/18/2029
Last patent03/17/2030
201620192022202520282031
- Latest patent
- 03/17/2030Vraylar Orange Book
- Exclusivity
- 06/18/2029Vraylar Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- First generic approved
- 09/09/2022 Orange Book
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 Vraylar profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $50.78 per unitVRAYLAR 4.5 MG CAPSULE, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Abbvie Inc Orange Book
- Application
- NDA 204370 Orange Book
- First approved
- 09/17/2015 Orange Book
- Dosage forms
- capsule
- 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.