FINERENONE - Generic Drug Details

What are the generic sources for finerenone and what is the scope of freedom to operate?

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

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

Sponsor	Phase
Saga University	Phase 4
Iain Bressendorff	Phase 2
National Natural Science Foundation of China	Phase 4

See all FINERENONE clinical trials

Pharmacology for FINERENONE

Drug Class	Nonsteroidal Mineralocorticoid-Receptor Antagonist
Mechanism of Action	Mineralocorticoid Receptor Antagonists

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				Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No			Y	Y
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes			Y	Y

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

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
Taiwan	200843755	Substituted 4-aryl-1, 4-dihydro-1, 6-naphthyridine amides and their use
World Intellectual Property Organization (WIPO)	2017032673
Taiwan	201722944	Process for preparing (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide and purificationthereof for use as a pharmaceutical activeingredient
Japan	6824247
Japan	5367586

Supplementary Protection Certificates for FINERENONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	C202230028	Spain		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	CA 2022 00025	Denmark		PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206	CR 2022 00025	Denmark		PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206	C02132206/01	Switzerland		PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
2132206	PA2022512	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	2290018-7	Sweden		PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. NO/DATE: EU/1/21/1616 20220217