Coreg Cr Patent Expiration

Coreg Cr is a drug owned by Waylis Therapeutics Llc. It is protected by 8 US drug patents filed in 2013. Out of these, 2 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 11, 2026. Details of Coreg Cr's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8101209

(Pediatric)

Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Mar, 2026

(1 year, 2 months from now)

Active
US8101209 Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles
Sep, 2025

(8 months from now)

Active
US7268156

(Pediatric)

Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment
Dec, 2023

(11 months ago)

Expired
US7268156 Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment
Jun, 2023

(1 year, 5 months ago)

Expired
US6022562

(Pediatric)

Medicinal and/or nutritional microcapsules for oral administration
Apr, 2016

(8 years ago)

Expired
USRE40000

(Pediatric)

Method of treatment for decreasing mortality resulting from congestive heart failure
Dec, 2015

(9 years ago)

Expired
US6022562 Medicinal and/or nutritional microcapsules for oral administration
Oct, 2015

(9 years ago)

Expired
USRE40000 Method of treatment for decreasing mortality resulting from congestive heart failure
Jun, 2015

(9 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Coreg Cr's patents.

Given below is the list of recent legal activities going on the following patents of Coreg Cr.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 21 Jun, 2023 US8101209 (Litigated)
Payment of Maintenance Fee, 12th Year, Large Entity 14 Feb, 2019 US7268156
Payment of Maintenance Fee, 8th Year, Large Entity 29 Jan, 2019 US8101209 (Litigated)
Post Issue Communication - Certificate of Correction 10 Apr, 2018 US8101209 (Litigated)
Email Notification 27 Mar, 2018 US8101209 (Litigated)
Change in Power of Attorney (May Include Associate POA) 27 Mar, 2018 US8101209 (Litigated)
Correspondence Address Change 26 Mar, 2018 US8101209 (Litigated)
Patent Issue Date Used in PTA Calculation 24 Jan, 2012 US8101209 (Litigated)
Recordation of Patent Grant Mailed 24 Jan, 2012 US8101209 (Litigated)
Issue Notification Mailed 04 Jan, 2012 US8101209 (Litigated)

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US patents provide insights into the exclusivity only within the United States, but Coreg Cr is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Coreg Cr's family patents as well as insights into ongoing legal events on those patents.

Coreg Cr's Family Patents

Coreg Cr has patent protection in a total of 17 countries. It's US patent count contributes only to 19.2% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Coreg Cr.

Family Patents

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Generic Launch

Generic Release Date:

Coreg Cr's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 11, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Coreg Cr Generic API suppliers:

Carvedilol Phosphate is the generic name for the brand Coreg Cr. 2 different companies have already filed for the generic of Coreg Cr, with Impax Labs Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Coreg Cr's generic

How can I launch a generic of Coreg Cr before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Coreg Cr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Coreg Cr's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Coreg Cr -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg and 20 mg 18 Mar, 2008 1 25 Oct, 2017 27 Dec, 2023 Deferred
40 mg 21 Dec, 2007 1 25 Oct, 2017 27 Dec, 2023 Deferred
80 mg 19 Nov, 2007 1 25 Oct, 2017 27 Dec, 2023 Deferred

Alternative Brands for Coreg Cr

Coreg Cr which is used for managing congestive heart failure and hypertension to reduce mortality., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Abbott
Hytrin Used for treating hypertension and symptomatic benign prostatic hyperplasia.
Abbvie
Teveten Used for managing high blood pressure.
Teveten Hct Used for managing high blood pressure.
Adhera
Prestalia Used for treating high blood pressure.
Allergan
Bystolic Used for treating high blood pressure.
Ani Pharms
Atacand Hct Used for treating high blood pressure.
Azurity
Edarbi Used for lowering blood pressure.
Epaned Used for managing heart failure and hypertension.
Edarbyclor Used for managing high blood pressure.
Boehringer Ingelheim
Twynsta Used for managing high blood pressure.
Micardis Used for the treatment of cardiovascular conditions such as myocardial infarction, hypertension, and stroke.
Micardis Hct Used for lowering high blood pressure.
Cosette
Azor Used for managing high blood pressure.
Benicar Used for lowering high blood pressure.
Tribenzor Used for lowering high blood pressure.
Benicar Hct Used for managing high blood pressure.
Noden Pharma
Tekturna Used for treating high blood pressure.
Tekturna Hct Used for lowering high blood pressure.
Novartis
Diovan Used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction.
Exforge Used for treating high blood pressure.
Tekamlo Used for treating high blood pressure.
Valturna Used for managing high blood pressure.
Amturnide Used for lowering high blood pressure (hypertension).
Diovan Hct Used for treating high blood pressure.
Exforge Hct Used for treating high blood pressure.
Upjohn
Inspra Used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor.





About Coreg Cr

Coreg Cr is a drug owned by Waylis Therapeutics Llc. It is used for managing congestive heart failure and hypertension to reduce mortality. Coreg Cr uses Carvedilol Phosphate as an active ingredient. Coreg Cr was launched by Waylis Therap in 2006.

Approval Date:

Coreg Cr was approved by FDA for market use on 20 October, 2006.

Active Ingredient:

Coreg Cr uses Carvedilol Phosphate as the active ingredient. Check out other Drugs and Companies using Carvedilol Phosphate ingredient

Treatment:

Coreg Cr is used for managing congestive heart failure and hypertension to reduce mortality.

Dosage:

Coreg Cr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG CAPSULE, EXTENDED RELEASE Prescription ORAL
10MG CAPSULE, EXTENDED RELEASE Prescription ORAL
40MG CAPSULE, EXTENDED RELEASE Prescription ORAL
80MG CAPSULE, EXTENDED RELEASE Prescription ORAL