COREG CR

Post-LOE

carvedilol phosphate

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2006
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
7

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.

Clinical Trials (5)

NCT00553969Phase 1/2Completed

Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

Started Nov 2007
101 enrolled
Pre-hypertension
NCT00557128Phase 1Completed

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
NCT00537043Phase 1Completed

A Study to Compare COREG CR to COREG CR Fixed-dose Combination in Patients With High Blood Pressure

Started Oct 2007
24 enrolled
Hypertension
NCT00556920Phase 1Completed

Study to Demonstrate the Bioequivalence of the Fixed Dose Combination of COREG CR™ and Lisinopril to Its Components

Started Oct 2007
50 enrolled
Hypertension
NCT00549510Phase 1Completed

Study to Investigate Dose Proportionality of the Fixed Dose Combination of COREG CR and Lisinopril.

Started Oct 2007
29 enrolled
Hypertension

Loss of Exclusivity

LOE Date
Mar 11, 2026
0 months away
Patent Expiry
Mar 11, 2026

Patent Records (2)

Patent #ExpiryTypeUse Code
8101209
Sep 11, 2025Expired
Product
8101209*PED
Mar 11, 2026