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
(8 months from now) | Active |
| US8101209 | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles |
Sep, 2025
(2 months from now) | Active |
|
US7268156 (Pediatric) | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US7268156 | Carvedilol phosphate salts and/or solvates thereof, corresponding compositions and/or methods of treatment |
Jun, 2023
(2 years ago) |
Expired
|
|
US6022562 (Pediatric) | Medicinal and/or nutritional microcapsules for oral administration |
Apr, 2016
(9 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
(10 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 27 Mar, 2018 | US8101209 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Mar, 2018 | US8101209 (Litigated) |
| Correspondence Address Change Critical | 26 Mar, 2018 | US8101209 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jan, 2012 | US8101209 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 24 Jan, 2012 | US8101209 (Litigated) |
| Issue Notification Mailed Critical | 04 Jan, 2012 | US8101209 (Litigated) |
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
Explore Our Curated Drug Screens
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 |
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| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |