Drug facts
MoleculeRosuvastatin (Crestor)
Generics already compete: 19 makers on the market. 76 A-rated products from 19 makers substitute at the counter.
Crestor was first approved by the FDA on 08/12/2003 under NDA 021366; the application holder is Astrazeneca UK Ltd.
The latest NADAC for ROSUVASTATIN CALCIUM 10 MG TAB is $0.04 per unit (as of 10/28/2026).
Holder Astrazeneca UK LtdApplication NDA 021366Approved 08/12/2003
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 Crestor patent listed in the Orange Book Orange Book
- Later patents, other products
- Ezallor Sprinkle 02/12/2036 Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- 04/29/2016 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 Rosuvastatin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.04 per unitROSUVASTATIN CALCIUM 10 MG TAB, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 12/31/2025Class II, Rosuvastatin, Avkare FDA enforcement
04Product
- Application holder
- Astrazeneca UK Ltd Orange Book
- Application
- NDA 021366 Orange Book
- First approved
- 08/12/2003 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.