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Last Updated: October 16, 2021

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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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Darolutamide has ninety-one patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide
International Patents:91
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 24
Patent Applications: 56
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
UNICANCERPhase 3
St Vincent's Hospital, SydneyPhase 2
Latin American Cooperative Oncology GroupPhase 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for darolutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2493858 2090018-9 Sweden ⤷  Free Forever Trial PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1432/001 20200330
2493858 PA2020514 Lithuania ⤷  Free Forever Trial PRODUCT NAME: DAROLUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858 301041 Netherlands ⤷  Free Forever Trial PRODUCT NAME: DAROLUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBARE ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1432 20200330
1986495 2018C/040 Belgium ⤷  Free Forever Trial PRODUCT NAME: VIBRANCE 52FS; AUTHORISATION NUMBER AND DATE: 15544 N
1986495 33/2019 Austria ⤷  Free Forever Trial PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Boehringer Ingelheim
Express Scripts
Harvard Business School
Colorcon

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