Drug facts
BrandNuplazid (Pimavanserin)
No generic pimavanserin has an active Orange Book listing (a generic was first approved 01/16/2024); the latest NDA 207318 patent or exclusivity in the Orange Book runs to 09/23/2037. 2 staged generic applications passed FDA review and wait on patents or exclusivity.
Nuplazid was first approved by the FDA on 04/29/2016 under NDA 207318; the application holder is Acadia Pharmaceuticals Inc.
The latest NADAC for NUPLAZID 34 MG CAPSULE is $170.50 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.
3,980days until the latest NDA 207318 patent expires
- Latest patent
- 09/23/2037Nuplazid Orange Book
- Exclusivity
- 10/27/2029Nuplazid Orange Book
- Later patents, other products
- Nuplazid (NDA 210793) 02/27/2039 Orange Book
02Competition
- Generics
- No active generic listing in the Orange Book Orange Book
- Staged generics
- 2 passed FDA review, awaiting market entry FDA
- First generic approved
- 01/16/2024 Orange Book
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $170.50 per unitNUPLAZID 34 MG CAPSULE, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Acadia Pharmaceuticals Inc Orange Book
- Application
- NDA 207318 Orange Book
- First approved
- 04/29/2016 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.