FINERENONE - Generic Drug Details
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What are the generic drug 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 |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Phase 4 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | 215341-001 | Jul 9, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341-001 | Jul 9, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 | Y | Y | ⤷ 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 |
---|---|---|---|
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 | ⤷ Try a Trial |
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 | ⤷ Try a Trial |
Malaysia | 176873 | SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDES AND THEIR USE | ⤷ Try a Trial |
Mexico | 367960 | PROCEDIMIENTO PARA LA PREPARACION DE (4S)-4-(4-CIANO-2-METOXIFENIL O)-5-ETOXI-2,8-DIMETILO-1,4-DIHIDRO-1,6-NAFTIRIDINA-3-CARBOXAMIDA Y SU PURIFICACION PARA SU USO COMO PRINCIPIO ACTIVO FARMACEUTICO. (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.) | ⤷ Try a Trial |
Japan | 6824247 | ⤷ Try a Trial | |
Russian Federation | 2470932 | ЗАМЕЩЕННЫЕ 4-АРИЛ-1,4-ДИГИДРО-1,6-НАФТИРИДИНАМИДЫ И ИХ ПРИМЕНЕНИЕ (SUBSTITUTED 4-ARYL-1,4-DIHYDRO-1,6-NAPHTHYRIDINE AMIDES AND USE THEREOF) | ⤷ 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 | 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 |
2132206 | 301192 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FINERENON EN ZIJN ZOUTEN, SOLVATEN EN SOLVATEN VAN DE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1616 20220217 |
2132206 | PA2022512 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: FINERENONAS; REGISTRATION NO/DATE: EU/1/21/1616 20220216 |
2132206 | 122022000030 | Germany | ⤷ Try a Trial | PRODUCT NAME: FINERENON, SOWIE DESSEN SALZE, SOLVATE UND SOLVATE DER SALZE; REGISTRATION NO/DATE: EU/1/21/1616 20220216 |
2132206 | C02132206/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: FINERENON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68130 26.11.2021 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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