Drug facts
MoleculeAripiprazole (Abilify)
Generics already compete: 22 makers on the market. 98 A-rated products from 22 makers substitute at the counter.
Abilify was first approved by the FDA on 11/15/2002 under NDA 021436; the application holder is Otsuka Pharmaceutical Co Ltd.
The latest NADAC for ARIPIPRAZOLE 5 MG TABLET is $0.12 per unit (as of 10/28/2026).
Holder Otsuka Pharmaceutical Co LtdApplication NDA 021436Approved 11/15/2002
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.
122days until the latest Abilify patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved11/15/2002
Last patent03/02/2027
2003200720112015201920232027
- Latest patent
- 03/02/2027Abilify Orange Book
- Later patents, other products
- Opipza 12/15/2041; Abilify Maintena Kit 04/01/2041; Abilify Mycite Kit 10/15/2033; Mezofy 08/07/2033; Abilify Asimtufii 04/23/2033 Orange Book
02Competition
- Generics
- 22 generic makers Orange Book
- Staged generics
- 5 passed FDA review, awaiting market entry FDA
- First generic approved
- 04/28/2015 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 Aripiprazole profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.12 per unitARIPIPRAZOLE 5 MG TABLET, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 05/27/2026Class II, Aripiprazole, Ajanta Pharma USA Inc FDA enforcement
04Product
- Application holder
- Otsuka Pharmaceutical Co Ltd Orange Book
- Application
- NDA 021436 Orange Book
- First approved
- 11/15/2002 Orange Book
- Dosage forms
- film; for suspension, extended release; solution; suspension, extended release; tablet; tablet, orally disintegrating
- Routes
- intramuscular, oral
- Other brand names
- Abilify AsimtufiiAbilify Maintena KitOpipza
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.