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Last Updated: January 31, 2023

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 is one patent protecting this drug.

This drug has fifty-seven patent family members in forty-three 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:57
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 22
Patent Applications: 149
What excipients (inactive ingredients) are in KERENDIA?KERENDIA excipients list
DailyMed Link:KERENDIA at DailyMed
Drug patent expirations by year for KERENDIA
DrugPatentWatch® Estimated Generic Entry Opportunity 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.

US Patents and Regulatory Information for KERENDIA

KERENDIA is protected by one US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KERENDIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting KERENDIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF FIGARO-DKD STUDY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-002 Jul 9, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Hlthcare KERENDIA finerenone TABLET;ORAL 215341-001 Jul 9, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 08221071
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0808098
Estimated Expiration: See Plans and Pricing

Patent: 2020008544
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79232
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08000502
Estimated Expiration: See Plans and Pricing

China

Patent: 1641352
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 20951
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 976
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150702
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 874
Estimated Expiration: See Plans and Pricing

Patent: 090148
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16455
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 32206
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 009000205
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 099581
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 32206
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2007009494
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0900230
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 09001597
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 40194
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26441
Estimated Expiration: See Plans and Pricing

Patent: 200015
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0060
Estimated Expiration: See Plans and Pricing

Japan

Patent: 67586
Estimated Expiration: See Plans and Pricing

Patent: 52754
Estimated Expiration: See Plans and Pricing

Patent: 10519232
Estimated Expiration: See Plans and Pricing

Patent: 14012678
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 18
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2022512
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0748
Estimated Expiration: See Plans and Pricing

Patent: 6873
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09008701
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 245
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9230
Estimated Expiration: See Plans and Pricing

Panama

Patent: 70101
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090724
Estimated Expiration: See Plans and Pricing

Poland

Patent: 32206
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 32206
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 70932
Estimated Expiration: See Plans and Pricing

Patent: 09135659
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 82
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 32206
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0905730
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1614164
Estimated Expiration: See Plans and Pricing

Patent: 090129992
Estimated Expiration: See Plans and Pricing

Spain

Patent: 40803
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 15608
Estimated Expiration: See Plans and Pricing

Patent: 74821
Estimated Expiration: See Plans and Pricing

Patent: 0843755
Estimated Expiration: See Plans and Pricing

Patent: 1340968
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 09000318
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2065
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 931
Estimated Expiration: See Plans and Pricing

Patent: 952
Estimated Expiration: See Plans and Pricing

Patent: 953
Estimated Expiration: See Plans and Pricing

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
Honduras 2009001597 4-ARIL-1, 4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO See Plans and Pricing
European Patent Office 2132206 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) See Plans and Pricing
Portugal 2132206 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: FINERENON UND SALZE, SOLVATE UND SOLVATE DER SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1616 (MITTEILUNG) 20220217
2132206 LUC00260 Luxembourg See Plans and Pricing 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 2290018-7 Sweden See Plans and Pricing PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. 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.