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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Finerenone has fifty-seven patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for finerenone

International Patents:	57
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	13
Patent Applications:	314
What excipients (inactive ingredients) are in finerenone?	finerenone excipients list
DailyMed Link:	finerenone at DailyMed

Recent Clinical Trials for finerenone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bayer	Phase 2
Bayer	N/A
Bayer	Phase 1

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

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
Cyprus	1116455
Guatemala	200900230	4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y USO
Israel	200060	4-אריל-1,4-דיהידרו-1,6-נפתירידינאמידים מותמרים ושימוש בהם (Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof)
Jordan	3018	مُركبات 4- أريل- 1 , 4 - ثنائي هيدرو -1 , 6- نافثيريدين أميد amides مُستبدلة وإستعمالها (Substituted 4-aryl-1,4-dihydro-1,6-naphthyridine amides and their use)

Supplementary Protection Certificates for finerenone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2132206	PA2022512	Lithuania		PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206	C02132206/01	Switzerland		PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
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	2022C/538	Belgium		PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217