TheraRadar
Data updated: May 26, 2026

COREG CR (carvedilol phosphate)

Cardiovascular Approved 2006-10-20

Coreg CR treats mild to severe chronic heart failure and helps patients manage high blood pressure. It is also used for stable patients who have survived a heart attack and have a left ventricular ejection fraction of 40% or less. This medication helps increase survival and reduces the likelihood of hospital visits for those with heart failure.

Source: FDA Label • WAYLIS THERAP

How COREG CR Works

This medication works by blocking both alpha-1 and beta-adrenergic receptors. It is a mixture where one part provides nonselective beta-blocking activity and both parts provide alpha-1 blocking activity. This combined action helps regulate cardiovascular function without stimulating the sympathetic nervous system.

2
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-10-20
Patent Cliff
2026

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Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: CARVEDILOL PHOSPHATE

COREG CR Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
60 FDA actions from 2006 to 2023
Jul 2023 SUPPL
Label · Labeling
Sep 2017 SUPPL
Label · Labeling
Oct 2015 SUPPL
Label · Labeling

What COREG CR Treats

4 indications

COREG CR is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heart Failure
  • Left Ventricular Dysfunction
  • Myocardial Infarction
  • Hypertension
Source: FDA Label

COREG CR Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to COREG CR

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CARVEDILOL PHOSPHATE
CARVEDILOL PHOSPHATE
4 shared
Sun Pharma
Shared indications:
Heart FailureLeft Ventricular DysfunctionMyocardial Infarction +1 more
COREG
CARVEDILOL
4 shared
WAYLIS THERAP
Shared indications:
Heart FailureLeft Ventricular DysfunctionMyocardial Infarction +1 more
DIOVAN
VALSARTAN
4 shared
Novartis
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

COREG CR FDA Label Details

Indications & Usage

FDA Label (PDF)

COREG CR is indicated for the treatment of Heart Failure; Left Ventricular Dysfunction; Myocardial Infarction; Hypertension.

View full patent landscape →
2 OB patents · 1 families · 8 international docs across 6 countries

COREG CR Patents & Exclusivity

Latest Patent: Mar 2026

Patents (2 active)

US8101209*PED Expires Mar 11, 2026
US8101209 Expires Sep 11, 2025
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2026
  • 32 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.