Drug facts
MoleculeSimvastatin (Zocor)
Generics already compete: 10 makers on the market. 49 A-rated products from 10 makers substitute at the counter.
Zocor was first approved by the FDA on 12/23/1991 under NDA 019766; the application holder is Organon LLC A Sub of Organon and Co.
The latest NADAC for SIMVASTATIN 5 MG TABLET is $0.03 per unit (as of 10/28/2026).
Holder Organon LLC A Sub of Organon and CoApplication NDA 019766Approved 12/23/1991
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 Zocor patent listed in the Orange Book Orange Book
- Later patents, other products
- Flolipid 02/23/2030 Orange Book
02Competition
- Generics
- 10 generic makers Orange Book
- First generic approved
- 06/23/2006 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 Simvastatin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.03 per unitSIMVASTATIN 5 MG TABLET, mid-priced of 5 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 04/06/2023Class II, Simvastatin USP 40 Mg, Pd-RX Pharmaceuticals, Inc. FDA enforcement
04Product
- Application holder
- Organon LLC A Sub of Organon and Co Orange Book
- Application
- NDA 019766 Orange Book
- First approved
- 12/23/1991 Orange Book
- Dosage forms
- suspension; tablet
- Routes
- oral
- Other brand names
- Flolipid
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.