Drug facts
MoleculePravastatin
Generics already compete: 12 makers on the market. 47 A-rated products from 12 makers substitute at the counter.
Pravachol was first approved by the FDA on 10/31/1991 under NDA 019898; the application holder is Bristol Myers Squibb. The Orange Book lists NDA 019898 as discontinued.
The latest NADAC for PRAVASTATIN SODIUM 20 MG TAB is $0.06 per unit (as of 10/28/2026).
Holder Bristol Myers SquibbApplication NDA 019898Approved 10/31/1991
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 Pravachol patent listed in the Orange Book Orange Book
02Competition
- Generics
- 12 generic makers Orange Book
- First generic approved
- 04/24/2006 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 Pravastatin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.06 per unitPRAVASTATIN SODIUM 20 MG TAB, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/13/2025Class II, Pravastatin Sodium, Glenmark Pharmaceuticals Inc., USA FDA enforcement
04Product
- Application holder
- Bristol Myers Squibb Orange Book
- Application
- NDA 019898 Orange Book
- First approved
- 10/31/1991 Orange Book
- Dosage forms
- tablet
- Routes
- oral
- Status
- NDA 019898 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.