DAROLUTAMIDE - Generic Drug Details

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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-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:	62
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
NRG Oncology	Phase 2
Eli Lilly and Company	Phase 1
Celcuity Inc	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

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

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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	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
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		⤷ 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

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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 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

International Patents for DAROLUTAMIDE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20190126111	결정성 의약품의 제조	⤷ Sign Up
Hong Kong	1130629	FUNGICIDAL COMPOSITIONS	⤷ Sign Up
Croatia	P20211180		⤷ Sign Up
>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	122020000030	Germany	⤷ Sign Up	PRODUCT NAME: DAROLUTAMID; NAT. REGISTRATION NO/DATE: EU/1/20/1432 20200327; FIRST REGISTRATION: EU EU/ 1/2011432 20200327
2493858	C202030032	Spain	⤷ Sign Up	PRODUCT NAME: DAROLUTAMIDA, OPCIONALMENTE EN FORMA DE SAL O ESTER FARMACEUTICAMENTE ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1432; DATE OF AUTHORISATION: 20200327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1432; DATE OF FIRST AUTHORISATION IN EEA: 20200327
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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