~ Buy the NUBEQA (darolutamide) Drug Profile, 2024 PDF Report in the Report Store ~

NUBEQA Drug Patent Profile

Which patents cover Nubeqa, and what generic alternatives are available?

Nubeqa is a drug marketed by Bayer Healthcare and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two patent family members in thirty-six countries.

The generic ingredient in NUBEQA is darolutamide. One supplier is listed for this compound. Additional details are available on the darolutamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Nubeqa

Nubeqa was eligible for patent challenges on July 30, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2038. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for NUBEQA

International Patents:	122
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	12
Patent Applications:	150
Drug Prices:	Drug price information for NUBEQA
What excipients (inactive ingredients) are in NUBEQA?	NUBEQA excipients list
DailyMed Link:	NUBEQA at DailyMed

See drug prices for NUBEQA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NUBEQA

NDA:

212099

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 NUBEQA

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

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

See all NUBEQA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NUBEQA

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

Paragraph IV (Patent) Challenges for NUBEQA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUBEQA	Tablets	darolutamide	300 mg	212099	1	2023-07-31

US Patents and Regulatory Information for NUBEQA

NUBEQA is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NUBEQA

FDA Regulatory Exclusivity protecting NUBEQA

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
Bayer Healthcare	NUBEQA	darolutamide	TABLET;ORAL	212099-001	Jul 30, 2019		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for NUBEQA

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 NUBEQA

When does loss-of-exclusivity occur for NUBEQA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

South Korea

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NUBEQA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2021020935	安定結晶形のカルボキサミド誘導体およびそのジアステレオマー (CARBOXAMIDE DERIVATIVE AND ITS DIASTEREOMERS IN STABLE CRYSTALLINE FORM)
Eurasian Patent Organization	201992103	ПОЛУЧЕНИЕ КРИСТАЛЛИЧЕСКОГО ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА
World Intellectual Property Organization (WIPO)	2007090624
Russian Federation	2008136205	ФУНГИЦИДНАЯ КОМПОЗИЦИЯ

Supplementary Protection Certificates for NUBEQA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1986495	CA 2020 00009	Denmark		PRODUCT NAME: SEDAXAN ELLER EN TAUTOMER DERAF, FLUDIOXONIL OG METALAXYL M; NAT. REG. NO/DATE: 1-235 20191015; FIRST REG. NO/DATE: NL 15544 N 20171229
2493858	SPC/GB20/022	United Kingdom		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	301041	Netherlands		PRODUCT NAME: DAROLUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN OF IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBARE ESTER DAARVAN; REGISTRATION NO/DATE: EU/1/20/1432 20200330
2493858	2020018	Norway		PRODUCT NAME: DAROLUTAMID, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER ESTER DERAV; REG. NO/DATE: EU/1/20/1432/ 20200401