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Last Updated: October 6, 2022

Darolutamide - Generic Drug Details


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What are the generic sources for darolutamide and what is the scope of freedom to operate?

Darolutamide is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Darolutamide has one hundred and thirteen patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide
International Patents:113
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 42
Patent Applications: 384
What excipients (inactive ingredients) are in darolutamide?darolutamide excipients list
DailyMed Link:darolutamide at DailyMed
Recent Clinical Trials for darolutamide

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

SponsorPhase
Institut BergoniéPhase 2
BayerPhase 4
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolPhase 2

See all darolutamide clinical trials

US Patents and Regulatory Information for darolutamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 darolutamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bayer AG Nubeqa darolutamide EMEA/H/C/004790
Nubeqa is indicated for the treatment of adult men with non metastatic castration resistant prostate cancer (nmCRPC) who are at risk of developing metastatic disease.
Authorised no no no 2020-03-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for darolutamide

Country Patent Number Title Estimated Expiration
Chile 2012000772 Compuestos derivados de hetorociclos carboxamidicos sustituidos, antagonista ar; composición farmacéutica que los comprende; y uso en el tratamiento del cáncer de próstata. See Plans and Pricing
Serbia 57592 JEDINJENJA KOJA MODULIRAJU ANDROGENI RECEPTOR (ANDROGEN RECEPTOR MODULATING COMPOUNDS) See Plans and Pricing
Serbia 63477 DERIVAT KARBOKSAMIDA I NJEGOVI DIJASTEREOIZOMERI U STABILNOM KRISTALNOM OBLIKU (A CARBOXAMIDE DERIVATIVE AND ITS DIASTEREOMERS IN STABLE CRYSTALLINE FORM) See Plans and Pricing
Ukraine 109535 ГЕТЕРОЦИКЛІЧНІ КАРБОКСАМІДИ, ЯКІ МОДУЛЮЮТЬ АНДРОГЕНОВІ РЕЦЕПТОРИ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ НА ЇХ ОСНОВІ ТА СПОСІБ ЛІКУВАННЯ ЗАХВОРЮВАНЬ See Plans and Pricing
Argentina 078793 DERIVADOS DE CARBOXAMIDAS NO ESTEROIDALES Y ACIL HIDRAZONA MODULADORES DE RECEPTORES ANDROGENICOS DE TEJIDO SELECTIVO (SARM), COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN Y USO DE LOS MISMOS EN EL TRATAMIENTO DEL CANCER DE PROSTATA ENTRE OTROS See Plans and Pricing
Lithuania PA2020514 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for darolutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1986495 33/2019 Austria See Plans and Pricing PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
2493858 C202030032 Spain See Plans and Pricing PRODUCT NAME: DAROLUTAMIDA, OPCIONALMENTE EN FORMA DE SAL O ESTER FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1432; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1432; DATE OF FIRST AUTHORISATION IN EEA: 20200327
2493858 20C1028 France See Plans and Pricing PRODUCT NAME: DAROLUTAMIDE Y COMPRIS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET SES ESTERS COUVERTS PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/20/1432/001 20200330
2493858 C20200015 00323 Estonia See Plans and Pricing PRODUCT NAME: DAROLUTAMIID;REG NO/DATE: EU/1/20/1432 30.03.2020
1986495 CA 2020 00009 Denmark See Plans and Pricing PRODUCT NAME: SEDAXAN ELLER EN TAUTOMER DERAF, FLUDIOXONIL OG METALAXYL M; NAT. REG. NO/DATE: 1-235 20191015; FIRST REG. NO/DATE: NL 15544 N 20171229
2493858 2020018 Norway See Plans and Pricing PRODUCT NAME: DAROLUTAMID, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER ESTER DERAV; REG. NO/DATE: EU/1/20/1432/ 20200401
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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