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Last Updated: May 1, 2024

Finerenone - Generic Drug Details


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

Finerenone is the generic ingredient in one branded drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Finerenone has ninety-three patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for finerenone
International Patents:93
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 20
Patent Applications: 281
What excipients (inactive ingredients) are in finerenone?finerenone excipients list
DailyMed Link:finerenone at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for finerenone
Generic Entry Date for finerenone*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for finerenone

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

SponsorPhase
Saga UniversityPhase 4
Iain BressendorffPhase 2
Vifor PharmaPhase 3

See all finerenone clinical trials

Pharmacology for finerenone

US Patents and Regulatory Information for finerenone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-002 Jul 9, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-002 Jul 9, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for finerenone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bayer AG Kerendia finerenone EMEA/H/C/005200
Kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
Authorised no no no 2022-02-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for finerenone

Country Patent Number Title Estimated Expiration
Mexico 2018002027 PROCEDIMIENTO PARA LA PREPARACION DE (4S)-4-(4-CIANO-2-METOXIFENIL O)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACION PARA SU USO COMO PRINCIPIO ACTIVO FARMACEUTICO. (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.) ⤷  Try a Trial
Croatia P20150702 ⤷  Try a Trial
Serbia 59055 POSTUPAK ZA PROIZVODNJU (4S)-4-(4-CIJANO-2-METOKSIFENIL)-5-ETOKSI-2,8-DIMETIL-1,4-DIHIDRO-1,6-NAFTIRIDIN-3-KARBOKSAMIDA I NJEGOVO PREČIŠĆAVANJE U SVRHU UPOTREBE KAO FARMACEUTSKI AKTIVNE SUPSTANCE (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) ⤷  Try a Trial
Colombia 2018001466 Procedimiento para la preparación de (4s)-4-(4-ciano-2-metoxifenilo)-5-etoxi-2,8-dimetilo-1,4-dihidro-1,6-naftiridina-3-carboxamida y su purificación para su uso como principio activo farmacéutico ⤷  Try a Trial
Russian Federation 2470932 ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDES AND USE THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for finerenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2132206 C202230028 Spain ⤷  Try a Trial PRODUCT NAME: FINERENONA Y SUS SALES, SOLVATOS Y SOLVATOS DE LAS SALES; NATIONAL AUTHORISATION NUMBER: EU/1/21/1616; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1616; DATE OF FIRST AUTHORISATION IN EEA: 20220216
2132206 301192 Netherlands ⤷  Try a Trial PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206 CR 2022 00025 Denmark ⤷  Try a Trial PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206 22C1017 France ⤷  Try a Trial PRODUCT NAME: FINERENONE ET SES SELS, SOLVATES ET SOLVATES DES SELS.; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206 C02132206/01 Switzerland ⤷  Try a Trial PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.