Eplerenone Patent Expiration

Eplerenone is Used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor. It was first introduced by Upjohn Us 2 Llc in its drug Inspra on Sep 27, 2002. 10 different companies have introduced drugs containing Eplerenone.


Eplerenone Patents

Given below is the list of patents protecting Eplerenone, 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
Inspra US6863902

(Pediatric)

Immediate release eplerenone compositions Oct 10, 2020

(Expired)

Upjohn
Inspra US6410054

(Pediatric)

Immediate release eplerenone compositions Jun 08, 2020

(Expired)

Upjohn
Inspra US6495165

(Pediatric)

Eplerenone compositions having improved bioavailability Jun 08, 2020

(Expired)

Upjohn
Inspra US6534093

(Pediatric)

Immediate release eplerenone compositions Jun 08, 2020

(Expired)

Upjohn
Inspra US6558707

(Pediatric)

Immediate release eplerenone compositions Jun 08, 2020

(Expired)

Upjohn
Inspra US7157101

(Pediatric)

Micronized eplerenone compositions Jun 08, 2020

(Expired)

Upjohn
Inspra US6410524

(Pediatric)

Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease May 05, 2020

(Expired)

Upjohn
Inspra US6747020

(Pediatric)

Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor May 05, 2020

(Expired)

Upjohn
Inspra US6863902 Immediate release eplerenone compositions Apr 10, 2020

(Expired)

Upjohn
Inspra US6410054 Immediate release eplerenone compositions Dec 08, 2019

(Expired)

Upjohn
Inspra US6495165 Eplerenone compositions having improved bioavailability Dec 08, 2019

(Expired)

Upjohn
Inspra US6534093 Immediate release eplerenone compositions Dec 08, 2019

(Expired)

Upjohn
Inspra US6558707 Immediate release eplerenone compositions Dec 08, 2019

(Expired)

Upjohn
Inspra US7157101 Micronized eplerenone compositions Dec 08, 2019

(Expired)

Upjohn
Inspra US6410524 Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease Nov 05, 2019

(Expired)

Upjohn
Inspra US6747020 Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor Nov 05, 2019

(Expired)

Upjohn



Eplerenone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Eplerenone:

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
Eplerenone and IOP in Healthy Adults University of Florida NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
Early Aldo Blockade in Subclinical PA Xinjiang Medical University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3


Eplerenone Generic API Manufacturers

Several generic applications have been filed for Eplerenone. The first generic version for Eplerenone was by Chartwell Rx Sciences Llc and was approved on Jul 30, 2008. And the latest generic version is by Annora Pharma Private Ltd and was approved on Jun 2, 2023.

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