Carvedilol Patent Expiration

Carvedilol is Used for reducing mortality associated with congestive heart failure. It was first introduced by Waylis Therapeutics Llc in its drug Coreg on Sep 14, 1995. 18 different companies have introduced drugs containing Carvedilol.


Carvedilol Patents

Given below is the list of patents protecting Carvedilol, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Coreg USRE40000

(Pediatric)

Method of treatment for decreasing mortality resulting from congestive heart failure Dec 07, 2015

(Expired)

Waylis Therap
Coreg USRE40000 Method of treatment for decreasing mortality resulting from congestive heart failure Jun 07, 2015

(Expired)

Waylis Therap



Carvedilol's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Carvedilol:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial Dayanand Medical College and Hospital NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure Mayo Clinic NA TERMINATED
(Jun 1, 2026)
PHASE2
HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy Washington University School of Medicine NA TERMINATED
(May 1, 2026)
PHASE2
Cardioprotection in AML University of Virginia NA RECRUITING
(Apr 1, 2026)
PHASE2


Carvedilol Generic API Manufacturers

Several generic applications have been filed for Carvedilol. The first generic version for Carvedilol was by Teva Pharmaceuticals Usa Inc and was approved on Sep 5, 2007. And the latest generic version is by Mlv Pharma Llc and was approved on Dec 22, 2009.

Given below is the list of companies who have filed for Carvedilol generic, along with the locations of their manufacturing plants worldwide.