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Last Updated: October 31, 2024

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kerendia Drug Patent Profile


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When do Kerendia patents expire, and when can generic versions of Kerendia launch?

Kerendia is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in KERENDIA is finerenone. One supplier is listed for this compound. Additional details are available on the finerenone profile page.

DrugPatentWatch® Generic Entry Outlook for Kerendia

Kerendia will be eligible for patent challenges on July 9, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 12, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for kerendia
International Patents:93
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 5
Patent Applications: 103
Drug Prices: Drug price information for kerendia
What excipients (inactive ingredients) are in kerendia?kerendia excipients list
DailyMed Link:kerendia at DailyMed
Drug patent expirations by year for kerendia
Drug Prices for kerendia

See drug prices for kerendia

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for kerendia
Generic Entry Date for kerendia*:
Constraining patent/regulatory exclusivity:
NDA:
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 kerendia

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

SponsorPhase
University Medical Center GroningenPhase 4
Boehringer IngelheimPhase 4
University of North Carolina, Chapel HillPhase 2

See all kerendia clinical trials

US Patents and Regulatory Information for kerendia

kerendia is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of kerendia is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting kerendia

Substituted-4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting kerendia

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF FIGARO-DKD STUDY
Exclusivity Expiration: ⤷  Sign Up

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 215341-001 Jul 9, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
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 215341-002 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 Y ⤷  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 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 kerendia

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 kerendia

When does loss-of-exclusivity occur for kerendia?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5463
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS, SU USO EN LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE ENFERMEDADES CARDIOVASCULARES Y UN METODO PARA SU PREPARACION.
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08221071
Patent: Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0808098
Patent: 4-ARIL-1,4-DI-HIDRO-1,6-NAFTIRIDINAMIDAS SUBSTITUÍDAS E SEU USO
Estimated Expiration: ⤷  Sign Up

Patent: 2020008544
Patent: uso de 4-aril-1,4-di-hidro-1,6-naftiridinamidas substituídas, e medicamento
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 79232
Patent: AMIDES DE 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE SUBSTITUES ETUTILISATION DE CEUX-CI (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08000502
Patent: 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
Estimated Expiration: ⤷  Sign Up

China

Patent: 1641352
Patent: Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 20951
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 976
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0150702
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 874
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Patent: 090148
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16455
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 32206
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 009000205
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 099581
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 32206
Patent: AMIDES DE 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE SUBSTITUÉS ET UTILISATION DE CEUX-CI (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1017
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2007009494
Patent: Substituierte 4-Aryl-1, 4-dihydro-1,6-naphthyridinamide und ihre Verwendung (New 1,6-naphthyridine or 8-azaquinazoline derivatives useful for treating aldosteronism, hypertension, cardiac insufficiency, myocardial infarct sequelae, liver cirrhosis, renal insufficiency and stroke)
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 0900230
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y USO
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 09001597
Patent: 4-ARIL-1, 4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 40194
Patent: 取代的 -芳基- -二氫- -萘啶酰胺和其用途 (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF 4--14--16-)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 26441
Estimated Expiration: ⤷  Sign Up

Patent: 200015
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0060
Patent: 4-אריל-1,4-דיהידרו-1,6-נפתירידינאמידים מותמרים ושימוש בהם (Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 67586
Estimated Expiration: ⤷  Sign Up

Patent: 52754
Estimated Expiration: ⤷  Sign Up

Patent: 10519232
Estimated Expiration: ⤷  Sign Up

Patent: 14012678
Patent: SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDE AND USE THEREOF
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 18
Patent: مُركبات 4- أريل- 1 , 4 - ثنائي هيدرو -1 , 6- نافثيريدين أميد amides مُستبدلة وإستعمالها (Substituted 4-aryl-1,4-dihydro-1,6-naphthyridine amides and their use)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 2022512
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 0748
Patent: SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND THEIR USE
Estimated Expiration: ⤷  Sign Up

Patent: 6873
Patent: SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDES AND THEIR USE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09008701
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO. (CARBON BLACK PELLETS AND METHOD OF FORMING SAME.)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 245
Patent: الاميدات 4 أريل-1 ،4-ثنائي هيدرو-1،6-نافتيريدين المبدل وإستعمالها.
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1192
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9230
Patent: Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof
Estimated Expiration: ⤷  Sign Up

Panama

Patent: 70101
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1, 6-NAFTIRIDINA SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 090724
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 32206
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 32206
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 70932
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Patent: 09135659
Patent: ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 290071
Patent: مُركبات 4- أريل-4،1- ثنائي هيدرو-6،1- نافثيريدين أميدات مُستبدلة واستعمالها (Substituted 4-aryl-1,4-dihydro-1,6-naphthyridine amides and their use)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 32206
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0905730
Patent: Substituted 4-Aryl-1,4-Dihydro-1,6-Naphthyridinamides and use thereof
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1614164
Estimated Expiration: ⤷  Sign Up

Patent: 090129992
Patent: SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 40803
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 15608
Estimated Expiration: ⤷  Sign Up

Patent: 74821
Estimated Expiration: ⤷  Sign Up

Patent: 0843755
Patent: Substituted 4-aryl-1, 4-dihydro-1, 6-naphthyridine amides and their use
Estimated Expiration: ⤷  Sign Up

Patent: 1340968
Patent: Substituted 4-aryl-1,4-dihydro-1,6-naphthyridine amides and their use
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 09000318
Patent: SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 2065
Patent: ЗАМІЩЕНІ 4-АРИЛ-1,4-ДИГІДРО-1,6-НАФТИРИДИНАМІДИ І ЇХ ЗАСТОСУВАННЯ[ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 931
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Sign Up

Patent: 952
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y COMPOSICIONES FARMACÉU-TICAS QUE LAS CONTIENEN
Estimated Expiration: ⤷  Sign Up

Patent: 953
Patent: AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y COMPOSICIONES FARMACÉU-TICAS QUE LAS CONTIENEN
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering kerendia around the world.

Country Patent Number Title Estimated Expiration
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
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
Poland 2132206 ⤷  Sign Up
Russian Federation 2009135659 ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ ⤷  Sign Up
Cyprus 1116455 ⤷  Sign Up
Lithuania PA2022512 ⤷  Sign Up
Hungary E044574 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for kerendia

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CR 2022 00025 Denmark ⤷  Sign Up PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206 C02132206/01 Switzerland ⤷  Sign Up PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
2132206 CA 2022 00025 Denmark ⤷  Sign Up PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. 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
2132206 PA2022512 Lithuania ⤷  Sign Up PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 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
>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.