DAROLUTAMIDE - Generic Drug Details

What are the generic drug 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
Eli Lilly and Company	Phase 1/Phase 2
Bayer	Phase 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			Y	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

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
European Patent Office	3592732	FABRICATION D'UN PRODUIT PHARMACEUTIQUE CRISTALLIN (MANUFACTURE OF A CRYSTALLINE PHARMACEUTICAL PRODUCT)
China	102596910	Androgen receptor modulating compounds
Slovenia	2493858

Supplementary Protection Certificates for DAROLUTAMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	1890044-9	Sweden		PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND MEALAXYL M; NAT. REG. NO/DATE: 5444 20180608; FIRST REG.: NL 15544 N 20171229
2493858	2020/018	Ireland		PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/20/1432/001 20200330