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Last Updated: April 13, 2024

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KERENDIA Drug Patent Profile


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Which patents cover Kerendia, 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: 2
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
Saga UniversityPhase 4
National Natural Science Foundation of ChinaPhase 4
National Key Research and Development Program of ChinaPhase 4

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting KERENDIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF FIGARO-DKD STUDY
Exclusivity Expiration: ⤷  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
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 215341-002 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 ⤷  Try a Trial
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 ⤷  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 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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08221071
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0808098
Patent: 4-ARIL-1,4-DI-HIDRO-1,6-NAFTIRIDINAMIDAS SUBSTITUÍDAS E SEU USO
Estimated Expiration: ⤷  Try a Trial

Patent: 2020008544
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 79232
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08000502
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1641352
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 20951
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 976
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150702
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 874
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Patent: 090148
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16455
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 32206
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 009000205
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 099581
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 32206
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1017
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2007009494
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0900230
Patent: 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y USO
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 09001597
Patent: 4-ARIL-1, 4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 40194
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 26441
Estimated Expiration: ⤷  Try a Trial

Patent: 200015
Estimated Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

Japan

Patent: 67586
Estimated Expiration: ⤷  Try a Trial

Patent: 52754
Estimated Expiration: ⤷  Try a Trial

Patent: 10519232
Estimated Expiration: ⤷  Try a Trial

Patent: 14012678
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 18
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 2022512
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 0748
Estimated Expiration: ⤷  Try a Trial

Patent: 6873
Estimated Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

Morocco

Patent: 245
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1192
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9230
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 70101
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 090724
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 32206
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 32206
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 70932
Estimated Expiration: ⤷  Try a Trial

Patent: 09135659
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 290071
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 32206
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0905730
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1614164
Estimated Expiration: ⤷  Try a Trial

Patent: 090129992
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 40803
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 15608
Estimated Expiration: ⤷  Try a Trial

Patent: 74821
Estimated Expiration: ⤷  Try a Trial

Patent: 0843755
Estimated Expiration: ⤷  Try a Trial

Patent: 1340968
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 09000318
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 2065
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 931
Estimated Expiration: ⤷  Try a Trial

Patent: 952
Estimated Expiration: ⤷  Try a Trial

Patent: 953
Estimated Expiration: ⤷  Try a Trial

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
Canada 2995905 PROCEDE DE PREPARATION DE (4S)-4-(4-CYANO-2-METHOXYPHENYL)-5-ETHOXY-2,8-DIMETHYL-1,4-DIHYDRO-1,6-NAPHTYRIDINE-3-CARBOXAMIDE ET DE PURIFICATION DE CE DERNIER AFIN DE L'UTILISER EN TANT QUE PRINCIPE ACTIF PHARMACEUTIQUE (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
Peru 20090724 AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y SU USO ⤷  Try a Trial
Ecuador SP099581 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO ⤷  Try a Trial
Cuba 20090148 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO ⤷  Try a Trial
Denmark 3337800 ⤷  Try a Trial
Taiwan I725045 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KERENDIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2132206 15/2022 Austria ⤷  Try a Trial PRODUCT NAME: FINERENON UND SALZE, SOLVATE UND SOLVATE DER SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1616 (MITTEILUNG) 20220217
2132206 2290018-7 Sweden ⤷  Try a Trial PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. 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 CA 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 LUC00260 Luxembourg ⤷  Try a Trial PRODUCT NAME: FINERENONE, SES SELS ET SOLVATES AINSI QUE LES SOLVATES DES SELS DE FINERENONE; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217
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
>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.