Darolutamide - Generic Drug Details

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-two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	122
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

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

Sponsor	Phase
D'Or Institute for Research and Education	Phase 2
Praful Ravi	Phase 1/Phase 2
Institut Claudius Regaud	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				Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes				Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes				Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y	Y
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y	Y

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

International Patents for darolutamide

Country	Patent Number	Title	Estimated Expiration
Ukraine	126071	КРИСТАЛІЧНІ ЧАСТИНКИ N-((S)-1-(3-(3-ХЛОР-4-ЦІАНОФЕНІЛ)-1H-ПІРАЗОЛ-1-ІЛ)-ПРОПАН-2-ІЛ)-5-(1-ГІДРОКСІЕТИЛ)-1H-ПІРАЗОЛ-3-КАРБОКСАМІДУ (MANUFACTURE OF A CRYSTALLINE PHARMACEUTICAL PRODUCT)
Hungary	E055528
Serbia	63477	DERIVAT KARBOKSAMIDA I NJEGOVI DIJASTEREOIZOMERI U STABILNOM KRISTALNOM OBLIKU (A CARBOXAMIDE DERIVATIVE AND ITS DIASTEREOMERS IN STABLE CRYSTALLINE FORM)
Lithuania	3056485
Peru	20121058	COMPUESTOS QUE MODULAN EL RECEPTOR DE ANDROGENOS
Mexico	2012004867	COMPUESTOS QUE MODULAN EL RECEPTOR DE ANDROGENOS. (ANDROGEN RECEPTOR MODULATING COMPOUNDS.)

Supplementary Protection Certificates for darolutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2493858	CR 2020 00020	Denmark		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	33/2019	Austria		PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
2493858	2090018-9	Sweden		PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1432/001 20200330
1986495	2018C/040	Belgium		PRODUCT NAME: VIBRANCE 52FS; AUTHORISATION NUMBER AND DATE: 15544 N
2493858	PA2020514	Lithuania		PRODUCT NAME: DAROLUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858	2020C/514	Belgium		PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330