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Last Updated: June 23, 2024

Finerenone - Generic Drug Details


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What are the generic drug sources for finerenone and what is the scope of patent protection?

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
National Key Research and Development Program of ChinaPhase 4

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-002 Jul 9, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Chile 2008000502 COMPUESTOS DERIVADOS DE AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS; PROCEDIMIENTO DE PREPARACION; MEDICAMENTO; Y USO DEL COMPUESTO PARA EL TRATAMIENTO Y/O PROFILAXIS DE ALDOSTERONISMO, PRESION SANGUINEA ALTA, FALLO CARDIACO CRONICO, SEC ⤷  Sign Up
Chile 2018000427 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 ⤷  Sign Up
Uruguay 36864 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 ⤷  Sign Up
Guatemala 200900230 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y USO ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for finerenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2132206 301192 Netherlands ⤷  Sign Up PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206 C202230028 Spain ⤷  Sign Up 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 22C1017 France ⤷  Sign Up PRODUCT NAME: FINERENONE ET SES SELS, SOLVATES ET SOLVATES DES SELS.; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206 122022000030 Germany ⤷  Sign Up PRODUCT NAME: FINERENON, SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1616 20220216
>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.