Finerenone - Generic Drug Details

What are the generic drug sources for finerenone and what is the scope of patent protection?

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

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
Malaysia	150748	SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND THEIR USE
Ecuador	SP099581	4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO
Cyprus	1116455
Jordan	P20160186	طريقة لتحضير (4S)-4-(4- سيانو-2- ميثوكسي فينيل)-5-إيثوكسي-8،2- داي ميثيل-4،1- دايهيدرو-6،1- نفثيريدين-3- كربوكساميد وتنقيته للاستخدام كمقوم نشط دوائيا (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)
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
Saudi Arabia	08290071	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)
South Korea	20180041138	(4S)-4--5-에톡시-2,8-디메틸-1,4-디히드로-1,6-나프티리딘-3-카르복스아미드의 제조 방법 및 활성 제약 성분으로서 사용하기 위한 그의 정제

Supplementary Protection Certificates for finerenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122022000030	Germany		PRODUCT NAME: FINERENON, SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	22C1017	France		PRODUCT NAME: FINERENONE ET SES SELS, SOLVATES ET SOLVATES DES SELS.; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206	15/2022	Austria		PRODUCT NAME: FINERENON UND SALZE, SOLVATE UND SOLVATE DER SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1616 (MITTEILUNG) 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	301192	Netherlands		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206	LUC00260	Luxembourg		PRODUCT NAME: FINERENONE, SES SELS ET SOLVATES AINSI QUE LES SOLVATES DES SELS DE FINERENONE; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217