NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2006
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
COREG CR (carvedilol phosphate) by Viatris (2) is β-adrenoreceptor blocking activity is present in the s(-) enantiomer and α 1 -adrenergic blocking activity is present in both r(+) and s(-) enantiomers at equal potency. Approved for hypertension. First approved in 2006.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COREG CR is an extended-release oral capsule formulation of carvedilol phosphate, a non-selective beta-blocker with alpha-1 blocking activity. It is indicated for hypertension and pre-hypertension management. The drug works by blocking both β-adrenergic and α-1 adrenergic receptors, reducing sympathetic outflow and peripheral resistance.
$0.529MPart D
Post-LOEDeclining
Post-LOEPost-LOE lifecycle with minimal Part D spending ($529K, 2023) signals a mature, legacy product with reduced team investment and limited growth opportunities.
Mechanism of Action
β-adrenoreceptor blocking activity is present in the S(-) enantiomer and α 1 -adrenergic blocking activity is present in both R(+) and S(-) enantiomers at equal potency. Carvedilol has no intrinsic sympathomimetic activity.
Indications (1)
Clinical Trials (7)
Study to Examine the Effect of Food on the Pharmacokinetics of the Fixed Dose Combination of COREG CR and Lisinopril.
Started Nov 2007
24 enrolled
Hypertension
Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease
Started Nov 2007
101 enrolled
Pre-hypertension
Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.
Started Oct 2007
29 enrolled
Hypertension
A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure
Started Oct 2007
24 enrolled
Hypertension
Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components
Started Oct 2007
50 enrolled
Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.