Coreg is a drug owned by Waylis Therapeutics Llc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2015. Details of Coreg'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). | |||
|
USRE40000 (Pediatric) | Method of treatment for decreasing mortality resulting from congestive heart failure |
Dec, 2015
(8 years ago) |
Expired
|
| USRE40000 | Method of treatment for decreasing mortality resulting from congestive heart failure |
Jun, 2015
(9 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Coreg 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's family patents as well as insights into ongoing legal events on those patents.
Coreg's Family Patents
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Generic Launch
Generic Release Date:
Coreg's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 07, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Coreg Generic API suppliers:
Carvedilol is the generic name for the brand Coreg. 17 different companies have already filed for the generic of Coreg, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Coreg's generic
How can I launch a generic of Coreg before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Coreg's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Coreg'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3.125 mg, 6.25 mg, 12.5 mg and 25 mg |
Alternative Brands for Coreg
Coreg which is used for reducing mortality associated with congestive heart failure., has several other brand drugs using the same active ingredient (Carvedilol). 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 | |
|---|---|---|
| Waylis Therap |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Carvedilol, Coreg's active ingredient. Check the complete list of approved generic manufacturers for Coreg
About Coreg
Coreg is a drug owned by Waylis Therapeutics Llc. It is used for reducing mortality associated with congestive heart failure. Coreg uses Carvedilol as an active ingredient. Coreg was launched by Waylis Therap in 1997.
Approval Date:
Coreg was approved by FDA for market use on 29 May, 1997.
Active Ingredient:
Coreg uses Carvedilol as the active ingredient. Check out other Drugs and Companies using Carvedilol ingredient
Treatment:
Coreg is used for reducing mortality associated with congestive heart failure.
Dosage:
Coreg is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG | TABLET | Prescription | ORAL |
| 3.125MG | TABLET | Prescription | ORAL |
| 6.25MG | TABLET | Prescription | ORAL |
| 25MG | TABLET | Prescription | ORAL |