Finerenone - Generic Drug Details
✉ Email this page to a colleague
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
Generic Entry Date for finerenone*:
Constraining patent/regulatory exclusivity:
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 |
Pharmacology for finerenone
Drug Class | Nonsteroidal Mineralocorticoid-Receptor Antagonist |
Mechanism of Action | Mineralocorticoid Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for finerenone
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341-002 | Jul 9, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341-001 | Jul 9, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341-002 | Jul 9, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341-002 | Jul 9, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 |
---|---|---|---|
Peru | 20090724 | AMIDAS DE 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINA SUSTITUIDAS Y SU USO | ⤷ Try a Trial |
Costa Rica | 10976 | 4-ARIL-1,4-DIHIDRO-1,6-NAFTIRIDINAMIDAS SUSTITUIDAS Y SU USO | ⤷ Try a Trial |
Lithuania | 3337800 | ⤷ Try a Trial | |
New Zealand | 579230 | Substituted 4-aryl-1,4-dihydro-1,6-naphthyridinamides and use thereof | ⤷ Try a Trial |
Hong Kong | 1140194 | 取代的 -芳基- -二氫- -萘啶酰胺和其用途 (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINAMIDES AND USE THEREOF 4--14--16-) | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216 |
2132206 | CA 2022 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: FINERENONE OG DETS SALTE, SOLVATER OG SOLVATER AF SALTENE DERAF; REG. NO/DATE: EU/1/21/1616 20220217 |
2132206 | LUC00260 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: FINERENONE, SES SELS ET SOLVATES AINSI QUE LES SOLVATES DES SELS DE FINERENONE; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217 |
2132206 | 2022C/538 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1616 20220217 |
2132206 | 2290018-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FINERENONE AND ITS SALTS, SOLVATES AND SOLVATES OF THE SALT THEREOF; REG. NO/DATE: EU/1/21/1616 20220217 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.