Finerenone Patent Expiration

Finerenone was first introduced by Bayer Healthcare Pharmaceuticals Inc in its drug Kerendia on Jul 9, 2021.


Finerenone Patents

Given below is the list of patents protecting Finerenone, 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
Kerendia USRE49826 Method for the preparation of (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1-6-naphthyridine-3-carboxamide and the purification thereof for use as an active pharmaceutical ingredient Jul 29, 2035 Bayer Hlthcare
Kerendia US8436180 Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof Aug 26, 2033 Bayer Hlthcare



Finerenone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Finerenone:

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
A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria Bayer NA RECRUITING
(Sep 22, 2026)
PHASE3
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients Colorado Prevention Center NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease Sarfez Pharmaceuticals, Inc. NA WITHDRAWN
(Sep 1, 2026)
PHASE3
Finerenone for Premature Ovarian Insufficiency (POI) The University of Hong Kong-Shenzhen Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide University Medical Center Groningen NA COMPLETED
(Sep 1, 2026)
PHASE2
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria Bayer NA ACTIVE NOT RECRUITING
(Aug 19, 2026)
PHASE3
Precision T1D Platform - New Therapies for Cardio-Renal Complications Oregon Health and Science University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence National Cheng-Kung University Hospital NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists Colorado Prevention Center NA RECRUITING
(Jul 1, 2026)
PHASE3
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction Bayer NA RECRUITING
(Jun 1, 2026)
PHASE3
A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Children and Young Adults With Heart Failure and Left Ventricular Systolic Dysfunction Bayer NA RECRUITING
(Jun 1, 2026)
PHASE3
Effect of Finerenone in Patients With Non-diabetic Glomerulonephritis Alexandria University NA COMPLETED
(May 1, 2026)
PHASE2
FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors University Medical Center Groningen NA ENROLLING BY INVITATION
(Apr 1, 2026)
PHASE3
Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure Second Affiliated Hospital, School of Medicine, Zhejiang University NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
Finerenone and Renal Oxidative Stress University of Erlangen-Nürnberg Medical School NA COMPLETED
(Mar 1, 2026)
PHASE3


Finerenone Generic API Manufacturers

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


Finerenone News

Research Analyzes Finerenone Versus Spironolactone for Managing Chronic Kidney Disease in Type 2 Diabetes

31 Oct, 2025

Bayer and Sun Pharma collaborate on marketing and distributing a second brand of cardiac medication in India

18 Jan, 2024

Sun Pharma to distribute a specific brand of Bayer's Finerenone drug for treating CKD

17 Jan, 2024

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