➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
AstraZeneca
McKinsey
Boehringer Ingelheim
Express Scripts

Last Updated: May 25, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022012


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 022012 describes COREG CR, which is a drug marketed by Smithkline Beecham and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. Additional details are available on the COREG CR profile page.

The generic ingredient in COREG CR is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 022012
Tradename:COREG CR
Applicant:Smithkline Beecham
Ingredient:carvedilol phosphate
Patents:2
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022012
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012 NDA GlaxoSmithKline LLC 0007-3370 0007-3370-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3370-13)
COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012 NDA GlaxoSmithKline LLC 0007-3371 0007-3371-13 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3371-13)
Paragraph IV (Patent) Challenges for 022012
Tradename Dosage Ingredient NDA Submissiondate
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 2008-03-18
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 2007-12-21
COREG CR CAPSULE, EXTENDED RELEASE;ORAL carvedilol phosphate 022012 2007-11-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 27, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Mar 11, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Oct 20, 2006TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 27, 2023Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022012

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-003 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-001 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-002 Oct 20, 2006   Start Trial   Start Trial
Smithkline Beecham COREG CR carvedilol phosphate CAPSULE, EXTENDED RELEASE;ORAL 022012-004 Oct 20, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Colorcon
Express Scripts
Moodys
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.