You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 13, 2024

Eplerenone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for eplerenone and what is the scope of freedom to operate?

Eplerenone is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Annora Pharma, Breckenridge, Chartwell Rx, Prasco, Rising, Sandoz, Slate Run Pharma, Westminster Pharms, and Upjohn, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for eplerenone. Fourteen suppliers are listed for this compound.

Drug Prices for eplerenone

See drug prices for eplerenone

Recent Clinical Trials for eplerenone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 4
Vifor PharmaPhase 3
Mario Negri Institute for Pharmacological ResearchPhase 3

See all eplerenone clinical trials

Pharmacology for eplerenone
Drug ClassAldosterone Antagonist
Mechanism of ActionAldosterone Antagonists
Paragraph IV (Patent) Challenges for EPLERENONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INSPRA Injection eplerenone 0.75 mg/mL, 100 mL vial 021437 1 2009-06-05
INSPRA Tablets eplerenone 25 mg and 50 mg 021437 2 2006-09-27

US Patents and Regulatory Information for eplerenone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising EPLERENONE eplerenone TABLET;ORAL 214663-002 Mar 23, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Westminster Pharms EPLERENONE eplerenone TABLET;ORAL 207842-001 Oct 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Westminster Pharms EPLERENONE eplerenone TABLET;ORAL 207842-002 Oct 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for eplerenone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002 ⤷  Sign Up ⤷  Sign Up
Upjohn INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 ⤷  Sign Up ⤷  Sign Up
Upjohn INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.