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

Darolutamide has fifty-one patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	51
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	28
Clinical Trials:	9
Patent Applications:	14
DailyMed Link:	darolutamide at DailyMed

Recent Clinical Trials for darolutamide

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

Sponsor	Phase
Tulane University	Phase 3
Barbara Ann Karmanos Cancer Institute	Phase 3
MANA RBM	Phase 3

See all darolutamide clinical trials

Synonyms for darolutamide

1-[(2S)-2-Butanyl]-N-[(4,6-dimethyl-2-oxo-1,2-dihydro-3-pyridinyl)methyl]-3-methyl-6-[6-(1-piperazinyl)-3-pyridinyl]-1H-indole-4-car boxamide

1297538-32-9

1H-Pyrazole-3-carboxamide, N-((1S)-2-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-1-methylethyl)-5-(1-hydroxyethyl)-

1H-Pyrazole-3-carboxamide, N-[(1S)-2-[3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl]-1-methylethyl]-5-(1-hydroxyethyl)-

AKOS030526387

BAY 1841788

BAY-1841788

BAY-1841788)

BAY1841788

BDBM309979

BLIJXOOIHRSQRB-PXYINDEMSA-N

CS-5174

D11045

Darolutamide (JAN/USAN/INN)

Darolutamide (ODM-201)

Darolutamide [USAN]

DB12941

EX-A759

example 56 [US9657003]

FT-0700158

GTPL10439

HY-16985

J-690121

J3.501.129C

KS-00000TSX

MFCD29472270

N-((2S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-((1RS)-1-hydroxyethyl)-1H-pyrazole-3-carboxamide

N-((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol -1-yl)propan-2-yl)-3-(1-hydroxyethyl)-1H-pyrazole-5-carboxamide

N-((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-3-(1-hydroxyethyl)-1H-pyrazole-5-carboxamide

N-((S)-1-(3-(3-Chloro-4-cyanophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxy-ethyl)-1H-pyrazole-3-carboxamide

N-((S)-1-(3-(3-Chloro-4-cyanophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide

N-[(2S)-1-[3-(3-chloro-4-cyanophenyl)pyrazol-1-yl]propan-2-yl]-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide

NCGC00484078-01

Nubeqa

ODM-201

ODM-201;BAY-1841788

ODM201

S7559

SB18882

SCHEMBL13733117

SCHEMBL1814935

UNII-X05U0N2RCO

US9657003, 56

X05U0N2RCO

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	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

International Patents for darolutamide

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	021170
China	102596910
Portugal	3056485
South Korea	20160105927
South Korea	101654529