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Last Updated: June 24, 2024

Darolutamide - Generic Drug Details


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What are the generic drug sources for darolutamide and what is the scope of patent protection?

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-three patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide
International Patents:123
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
BayerPhase 1/Phase 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
2493858 C02493858/01 Switzerland ⤷  Sign Up PRODUCT NAME: DAROLUTAMIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67521 19.06.2020
1986495 33/2019 Austria ⤷  Sign Up PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
2493858 PA2020514,C2493858 Lithuania ⤷  Sign Up PRODUCT NAME: DAROLUTAMIDAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858 122020000030 Germany ⤷  Sign Up PRODUCT NAME: DAROLUTAMID; NAT. REGISTRATION NO/DATE: EU/1/20/1432 20200327; FIRST REGISTRATION: EU EU/ 1/2011432 20200327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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