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
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 |

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.
Pharmacology for KERENDIA
Drug Class | Nonsteroidal Mineralocorticoid-Receptor Antagonist |
Mechanism of Action | Mineralocorticoid Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for KERENDIA
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 |