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Last Updated: March 6, 2021

DrugPatentWatch Database Preview

Eplerenone - Generic Drug Details

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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, Breckenridge, Corepharma, Piramal Hlthcare Uk, Prasco, Sandoz, and Gd Searle Llc, and is included in seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Eplerenone has eighty-two patent family members in twenty-nine countries.

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

Drug Prices for eplerenone

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Recent Clinical Trials for eplerenone

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

SponsorPhase
AstraZenecaPhase 4
University of MichiganPhase 4
Northwestern UniversityPhase 4

See all eplerenone clinical trials

Pharmacology for eplerenone
Paragraph IV (Patent) Challenges for EPLERENONE
Tradename Dosage Ingredient NDA Submissiondate
INSPRA TABLET;ORAL eplerenone 021437 2009-06-05
INSPRA TABLET;ORAL eplerenone 021437 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
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Accord Hlthcare EPLERENONE eplerenone TABLET;ORAL 206922-001 Jul 13, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge EPLERENONE eplerenone TABLET;ORAL 208283-002 Sep 14, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Prasco EPLERENONE eplerenone TABLET;ORAL 203896-001 Feb 2, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-003 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-002 Sep 27, 2002   Start Trial   Start Trial
Gd Searle Llc INSPRA eplerenone TABLET;ORAL 021437-001 Sep 27, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for eplerenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0122232 2004C/008 Belgium   Start Trial PRODUCT NAME: EPLERENONE; NATIONAL REGISTRATION NO/DATE: 241 IS 188 F3 20041220; FIRST REGISTRATION: NL RVG 29963 20040316
1135139 C01135139/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Medtronic
Baxter
McKesson
Express Scripts

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.