Drug facts
BrandInvega Sustenna (Paliperidone Palmitate)
No generic paliperidone palmitate is approved; the latest Invega Sustenna patent or exclusivity in the Orange Book runs to 01/26/2031. 5 staged generic applications passed FDA review and wait on patents or exclusivity.
Invega Sustenna was first approved by the FDA on 07/31/2009 under NDA 022264; the application holder is Janssen Pharmaceuticals Inc.
The latest NADAC for INVEGA SUSTENNA 117 MG/0.75 ML is $2,337.67 per mL (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.
1,548days until the latest Invega Sustenna patent expires
- Latest patent
- 01/26/2031Invega Sustenna Orange Book
- Later patents, other products
- Invega Hafyera 11/24/2041; Erzofri 09/24/2039 Orange Book
02Competition
- Generics
- No generic approved Orange Book
- Staged generics
- 5 passed FDA review, awaiting market entry FDA
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $2,337.67 per mLINVEGA SUSTENNA 117 MG/0.75 ML, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
04Product
- Application holder
- Janssen Pharmaceuticals Inc Orange Book
- Application
- NDA 022264 Orange Book
- First approved
- 07/31/2009 Orange Book
- Dosage forms
- suspension, extended release
- Routes
- intramuscular
- Other brand names
- ErzofriInvega HafyeraInvega Trinza
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.