Drug facts
MoleculeSpironolactone (Aldactone)
Generics already compete: 12 makers on the market. 32 A-rated products from 12 makers substitute at the counter.
Aldactone was first approved by the FDA on 12/30/1982 under NDA 012151; the application holder is Pfizer Inc.
The latest NADAC for SPIRONOLACTONE 50 MG TABLET is $0.08 per unit (as of 10/28/2026).
Holder Pfizer IncApplication NDA 012151Approved 12/30/1982
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.
- Latest patent
- No Aldactone patent listed in the Orange Book Orange Book
- Later patents, other products
- Carospir 10/28/2036 Orange Book
02Competition
- Generics
- 12 generic makers Orange Book
- First generic approved
- before 1982 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 Spironolactone profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.08 per unitSPIRONOLACTONE 50 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/05/2025Class II, Spironolactone, Sun Pharmaceutical Industries Inc FDA enforcement
04Product
- Application holder
- Pfizer Inc Orange Book
- Application
- NDA 012151 Orange Book
- First approved
- 12/30/1982 Orange Book
- Dosage forms
- suspension; tablet
- Routes
- oral
- Other brand names
- Carospir
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.