Drug facts
MoleculeCarvedilol (Coreg)
Generics already compete: 10 makers on the market. 40 A-rated products from 10 makers substitute at the counter.
Coreg was first approved by the FDA on 09/14/1995 under NDA 020297; the application holder is Waylis Therapeutics LLC.
The latest NADAC for CARVEDILOL 3.125 MG TABLET is $0.02 per unit (as of 10/28/2026).
Holder Waylis Therapeutics LLCApplication NDA 020297Approved 09/14/1995
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 Coreg patent listed in the Orange Book Orange Book
02Competition
- Generics
- 10 generic makers Orange Book
- First generic approved
- 09/05/2007 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 Carvedilol profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.02 per unitCARVEDILOL 3.125 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/20/2025Class II, Carvedilol, The Harvard Drug Group LLC Dba Major Pharmaceuticals and Rugby Laboratories FDA enforcement
04Product
- Application holder
- Waylis Therapeutics LLC Orange Book
- Application
- NDA 020297 Orange Book
- First approved
- 09/14/1995 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.