Drug facts
BrandRexulti (Brexpiprazole)
No generic brexpiprazole has an active Orange Book listing (a generic was first approved 08/11/2022); the latest Rexulti patent or exclusivity in the Orange Book runs to 04/12/2033. 4 staged generic applications passed FDA review and wait on patents or exclusivity.
Rexulti was first approved by the FDA on 07/10/2015 under NDA 205422; the application holder is Otsuka Pharmaceutical Co Ltd.
The latest NADAC for REXULTI 3 MG TABLET is $49.49 per unit (as of 10/28/2026).
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.
2,356days until the latest patent expires
- Latest patent
- 04/12/2033Rexulti Orange Book
- Exclusivity
- 05/09/2028Rexulti Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 4 passed FDA review, awaiting market entry FDA
- First generic approved
- 08/11/2022 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $49.49 per unitREXULTI 3 MG TABLET, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Otsuka Pharmaceutical Co Ltd Orange Book
- Application
- NDA 205422 Orange Book
- First approved
- 07/10/2015 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.