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Last Updated: February 29, 2024

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 twenty-one patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide
International Patents:121
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 46
Clinical Trials: 54
Patent Applications: 363
What excipients (inactive ingredients) are in darolutamide?darolutamide excipients list
DailyMed Link:darolutamide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for darolutamide
Generic Entry Date for darolutamide*:
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 darolutamide

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

SponsorPhase
D'Or Institute for Research and EducationPhase 2
Eli Lilly and CompanyPhase 1/Phase 2
Erasmus Medical CenterPhase 2

See all darolutamide clinical trials

Paragraph IV (Patent) Challenges for DAROLUTAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NUBEQA Tablets darolutamide 300 mg 212099 1 2023-07-31

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 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 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 high risk of developing metastatic disease (see section 5.1).- metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).
Authorised no no no 2020-03-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for darolutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1986495 33/2019 Austria ⤷  Try a Trial 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 ⤷  Try a Trial 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 C02493858/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DAROLUTAMIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67521 19.06.2020
1986495 CR 2020 00009 Denmark ⤷  Try a 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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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.