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Last Updated: January 30, 2023

Finerenone - Generic Drug Details


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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

SponsorPhase
BayerPhase 2
BayerN/A
BayerPhase 1

See all finerenone clinical trials

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 See Plans and Pricing See Plans and Pricing 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 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 215341-002 Jul 9, 2021 RX Yes Yes 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 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for finerenone

Country Patent Number Title Estimated Expiration
Cyprus 1116455 See Plans and Pricing
Guatemala 200900230 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y USO See Plans and Pricing
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) See Plans and Pricing
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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for finerenone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2132206 PA2022512 Lithuania See Plans and Pricing PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216
2132206 C02132206/01 Switzerland See Plans and Pricing PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021
2132206 301192 Netherlands See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon
McKinsey
Mallinckrodt

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