Drug facts
BrandAustedo (Deutetrabenazine)
No generic deutetrabenazine has an active Orange Book listing (a generic was first approved 12/26/2024); the latest Austedo patent or exclusivity in the Orange Book runs to 09/15/2038.
Austedo was first approved by the FDA on 04/03/2017 under NDA 208082; the application holder is Teva Branded Pharmaceutical Products R and D LLC.
The latest NADAC for AUSTEDO XR 24 MG TABLET is $250.32 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.
4,338days until the latest Austedo patent expires
- Latest patent
- 09/15/2038Austedo Orange Book
- Later patents, other products
- Austedo XR 06/10/2041 Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- First generic approved
- 12/26/2024 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $250.32 per unitAUSTEDO XR 24 MG TABLET, mid-priced of 11 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Teva Branded Pharmaceutical Products R and D LLC Orange Book
- Application
- NDA 208082 Orange Book
- First approved
- 04/03/2017 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Other brand names
- Austedo XR
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.