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.

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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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.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

tablet Prescription ORAL AB Jul 13, 2017
25MG

tablet Prescription ORAL AB Jul 13, 2017





2. ADAPTIS

Adaptis Pharma Private Ltd has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Adaptis.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Aug 10, 2020
50MG

tablet Prescription ORAL AB Aug 10, 2020





3. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Annora Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Jun 2, 2023
50MG

tablet Prescription ORAL AB Jun 2, 2023


Manufacturing Plant Locations
New

Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





4. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Sep 14, 2018
50MG

tablet Prescription ORAL AB Sep 14, 2018


Manufacturing Plant Locations
New

Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.

Country City Firm Name
United States
Boca Raton Breckenridge Pharmaceutical, Inc.
Berlin Breckenridge Pharmaceutical, Inc





5. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Jul 30, 2008
50MG

tablet Prescription ORAL AB Jul 30, 2008





6. PRASCO

Prasco Llc Dba Prasco Laboratories has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Prasco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Discontinued ORAL N/A Feb 2, 2017
50MG

tablet Discontinued ORAL N/A Feb 2, 2017


Manufacturing Plant Locations
New

Prasco's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Prasco as present at those locations.

Country City Firm Name
United States
Mason Prasco LLC





7. RISING

Rising Pharma Holdings Inc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Mar 23, 2022
50MG

tablet Prescription ORAL AB Mar 23, 2022


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





8. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Aug 1, 2008
50MG

tablet Prescription ORAL AB Aug 1, 2008


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Langkampfen Sandoz GmbH
Kundl Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Les Franqueses Del Valles Sandoz Industrial Products S.A.
Palafolls Sandoz Industrial Products, S.A.
India
Navi Mumbai Sandoz Private Limited





9. WESTMINSTER PHARMS

Westminster Pharmaceuticals Llc has filed for 2 different strengths of generic version for Eplerenone. Given below are the details of the strengths of this generic introduced by Westminster Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet Prescription ORAL AB Oct 25, 2021
50MG

tablet Prescription ORAL AB Oct 25, 2021