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Last Updated: May 6, 2024

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-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

Generic Entry Date for darolutamide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
>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
Australia	2007213960	Fungicidal compositions	⤷ Try a Trial
Spain	2486263		⤷ Try a Trial
Chile	2012000772	Compuestos derivados de hetorociclos carboxamidicos sustituidos, antagonista ar; composición farmacéutica que los comprende; y uso en el tratamiento del cáncer de próstata.	⤷ Try a Trial
Chile	2023002780	Fabricación de un producto farmacéutico cristalino	⤷ Try a Trial
Hungary	E055528		⤷ Try a Trial
Serbia	63477	DERIVAT KARBOKSAMIDA I NJEGOVI DIJASTEREOIZOMERI U STABILNOM KRISTALNOM OBLIKU (A CARBOXAMIDE DERIVATIVE AND ITS DIASTEREOMERS IN STABLE CRYSTALLINE FORM)	⤷ Try a Trial
Australia	2010311299	Androgen receptor modulating compounds	⤷ Try a Trial
>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	SPC/GB20/022	United Kingdom	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTERED: UK EU/1/20/1432/001(NI) 20200330; UK PLGB 00010/0677 20200330
2493858	2090018-9	Sweden	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REG. NO/DATE: EU/1/20/1432/001 20200330
2493858	LUC00154	Luxembourg	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDE EVENTUELLEMENT SOUS LA FORME D'UN SEL OU D'UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1432/001 20200330
1986495	SPC/GB18/044	United Kingdom	⤷ Try a Trial	PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND METALAXYL M; REGISTERED: NL NL 15544 N 20171229; UK MAPP NO. 18588 20180619
2493858	PA2020514,C2493858	Lithuania	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858	2020C/514	Belgium	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330
2493858	C02493858/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: DAROLUTAMIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67521 19.06.2020
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.