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Last Updated: September 26, 2020

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

Darolutamide has eighty-two patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for darolutamide
International Patents:82
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 27
Clinical Trials: 17
Patent Applications: 14
DailyMed Link:darolutamide at DailyMed
Recent Clinical Trials for darolutamide

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

SponsorPhase
Latin American Cooperative Oncology GroupPhase 2
National Cancer Institute (NCI)Phase 3
ECOG-ACRIN Cancer Research GroupPhase 3

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   Start Trial   Start Trial Y Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start 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 CA 2020 00020 Denmark   Start Trial PRODUCT NAME: DAROLUTAMID EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER EN FARMACEUTISK ACCEPTABELT ESTER DERAF; REG. NO/DATE: EU/1/20/1432/001 20200330
1986495 122019000057 Germany   Start Trial PRODUCT NAME: SEDAXANE ODER EIN TAUTOMER HIERVON MIT METALAXYL-M UND MIT FLUDIOXONIL; NAT. REGISTRATION NO/DATE: 008594-00 20181218; FIRST REGISTRATION: NIEDERLANDE 15544 N 20171229
2493858 301041 Netherlands   Start 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   Start Trial PRODUCT NAME: VIBRANCE 52FS; AUTHORISATION NUMBER AND DATE: 15544 N
1986495 19C1035 France   Start Trial PRODUCT NAME: COMPOSITION COMPRENANT SEDAXANE OU UN TAUTOMERE DE CE COMPOSE, FLUDIOXONIL ET METALAXYL-M; NAT. REGISTRATION NO/DATE: 2180766 20181218; FIRST REGISTRATION: NL - 15544N 20171229
1986495 CA 2020 00009 Denmark   Start Trial 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
>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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