FINERENONE - Generic Drug Details

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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:	27
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

Generic Entry Date for FINERENONE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
The George Institute	Phase 3
University Medical Center Groningen	Phase 4
Boehringer Ingelheim	Phase 4

See all FINERENONE clinical trials

Pharmacology for FINERENONE

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

Anatomical Therapeutic Chemical (ATC) Classes for FINERENONE

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

US Patents and Regulatory Information for FINERENONE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-002	Jul 9, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bayer Hlthcare	KERENDIA	finerenone	TABLET;ORAL	215341-001	Jul 9, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>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 FINERENONE

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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 FINERENONE

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Country	Patent Number	Title	Estimated Expiration
Germany	102007009494	Substituierte 4-Aryl-1, 4-dihydro-1,6-naphthyridinamide und ihre Verwendung (New 1,6-naphthyridine or 8-azaquinazoline derivatives useful for treating aldosteronism, hypertension, cardiac insufficiency, myocardial infarct sequelae, liver cirrhosis, renal insufficiency and stroke)	⤷ Sign Up
Russian Federation	2009135659	ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ	⤷ Sign Up
Argentina	105774	PROCEDIMIENTO PARA LA PREPARACIÓN DE (4S)-4-(4-CIANO-2-METOXIFENILO)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACIÓN PARA SU USO COMO PRINCIPIO ACTIVO FARMACÉUTICO	⤷ Sign Up
Lithuania	PA2022512		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FINERENONE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	301192	Netherlands	⤷ Sign Up	PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 20220217
2132206	CA 2022 00025	Denmark	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217
2132206	15/2022	Austria	⤷ Sign Up	PRODUCT NAME: FINERENON UND SALZE, SOLVATE UND SOLVATE DER SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1616 (MITTEILUNG) 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.