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Last Updated: August 11, 2022

NUBEQA Drug Patent Profile


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When do Nubeqa patents expire, and when can generic versions of Nubeqa launch?

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

This drug has one hundred and eleven 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 will be eligible for patent challenges on July 30, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for NUBEQA
International Patents:111
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 9
Patent Applications: 167
Drug Prices: Drug price information for NUBEQA
What excipients (inactive ingredients) are in NUBEQA?NUBEQA excipients list
DailyMed Link:NUBEQA at DailyMed
Drug patent expirations by year for NUBEQA
Drug Prices for NUBEQA

See drug prices for NUBEQA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NUBEQA
Generic Entry Date for NUBEQA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
AstraZenecaPhase 1/Phase 2
NRG OncologyPhase 3
National Cancer Institute (NCI)Phase 3

See all NUBEQA clinical trials

US Patents and Regulatory Information for NUBEQA

NUBEQA is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUBEQA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Carboxamide derivative and its diastereomers in stable crystalline form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Carboxamide derivative and its diastereomers in stable crystalline form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Androgen receptor modulating compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Carboxamide derivative and its diastereomers in stable crystalline form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Androgen receptor modulating compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Manufacture of a crystalline pharmaceutical product
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Androgen receptor modulating compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Androgen receptor modulating compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

FDA Regulatory Exclusivity protecting NUBEQA

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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 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
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 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 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 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 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

Patent: 18229817
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2019018458
Estimated Expiration: See Plans and Pricing

Canada

Patent: 55019
Estimated Expiration: See Plans and Pricing

Chile

Patent: 19002540
Estimated Expiration: See Plans and Pricing

China

Patent: 0382467
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1992103
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 92732
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20510018
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 19010452
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190126111
Estimated Expiration: See Plans and Pricing

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
Lithuania 3250554 See Plans and Pricing
Hong Kong 1130629 FUNGICIDAL COMPOSITIONS See Plans and Pricing
European Patent Office 3056485 COMPOSÉS DE MODULATION DU RÉCEPTEUR D'ANDROGÈNES (ANDROGEN RECEPTOR MODULATING COMPOUNDS) See Plans and Pricing
European Patent Office 3369732 COMPOSÉS DE MODULATION DU RÉCEPTEUR D'ANDROGÈNES (ANDROGEN RECEPTOR MODULATING COMPOUNDS) See Plans and Pricing
Mexico 2019010452 FABRICACION DE UN PRODUCTO FARMACEUTICO CRISTALINO. (MANUFACTURE OF A CRYSTALLINE PHARMACEUTICAL PRODUCT.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUBEQA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1986495 2018C/040 Belgium See Plans and Pricing PRODUCT NAME: VIBRANCE 52FS; AUTHORISATION NUMBER AND DATE: 15544 N
2493858 2090018-9 Sweden See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: SEDAXANE OR A TAUTOMER THEREOF, FLUDIOXONIL AND MEALAXYL M; NAT. REG. NO/DATE: 5444 20180608; FIRST REG.: NL 15544 N 20171229
2493858 PA2020514,C2493858 Lithuania See Plans and Pricing PRODUCT NAME: DAROLUTAMIDAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ARBA ESTERIS; REGISTRATION NO/DATE: EU/1/20/1432 20200327
2493858 C202030032 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
AstraZeneca
McKesson
Merck
Dow

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.