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 patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for darolutamide

International Patents:	120
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	45
Patent Applications:	384
What excipients (inactive ingredients) are in darolutamide?	darolutamide excipients list
DailyMed Link:	darolutamide at DailyMed

Recent Clinical Trials for darolutamide

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

Sponsor	Phase
Eli Lilly and Company	Phase 1/Phase 2
Bayer	Phase 1/Phase 2
Praful Ravi	Phase 1/Phase 2

See all darolutamide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for darolutamide

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for darolutamide

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Glossary

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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	See Plans and Pricing	See Plans and Pricing		Y		See Plans and Pricing
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing		Y		See Plans and Pricing
>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

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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 risk of developing metastatic disease.	Authorised	no	no	no	2020-03-27
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for darolutamide

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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)	See Plans and Pricing
South Africa	200806874	Fungicidal compositions	See Plans and Pricing
Denmark	3056485		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for darolutamide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2493858	132020000000064	Italy	See Plans and Pricing	PRODUCT NAME: DAROLUTAMIDE(NUBEQA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1432, 20200330
1986495	SPC/GB18/044	United Kingdom	See Plans and Pricing	PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND METALAXYL M; REGISTERED: NL NL 15544 N 20171229; UK MAPP NO. 18588 20180619
1986495	122019000057	Germany	See Plans and Pricing	PRODUCT NAME: SEDAXANE ODER EIN TAUTOMER HIERVON MIT METALAXYL-M UND MIT FLUDIOXONIL; NAT. REGISTRATION NO/DATE: 008594-00 20181218; FIRST REGISTRATION: NIEDERLANDE 15544 N 20171229
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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