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Last Updated: March 28, 2024

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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 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

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  Try a Trial

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
Drug patent expirations by year for NUBEQA
Drug Prices for NUBEQA

See drug prices for NUBEQA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
BayerPhase 1/Phase 2
Praful RaviPhase 1/Phase 2
Eli Lilly and CompanyPhase 1/Phase 2

See all NUBEQA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUBEQA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Carboxamide derivative and its diastereomers in stable crystalline form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Androgen receptor modulating compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Carboxamide derivative and its diastereomers in stable crystalline form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Androgen receptor modulating compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Manufacture of a crystalline pharmaceutical product
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Androgen receptor modulating compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Androgen receptor modulating compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

FDA Regulatory Exclusivity protecting NUBEQA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONE‐SENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL
Exclusivity Expiration: ⤷  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
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 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 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 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
>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: ⤷  Try a Trial

Brazil

Patent: 2019018458
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 55019
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 19002540
Estimated Expiration: ⤷  Try a Trial

Patent: 23002780
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0382467
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1992103
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 92732
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 57071
Estimated Expiration: ⤷  Try a Trial

Patent: 20510018
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 19010452
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 190126111
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 6071
Estimated Expiration: ⤷  Try a Trial

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 2009526001 ⤷  Try a Trial
Hong Kong 1130629 FUNGICIDAL COMPOSITIONS ⤷  Try a Trial
Israel 238044 2-כלורו-4-(h1-פיראזול-5-איל)בנזוניטריל ו-(s)-4-(1-(2-אמינופרופיל)-h1-פיראזול-3-איל)-2-כלורו- בנזוניטריל כחומרי ביניים בתהליך להכנת (s)-3-אצטיל-n-1-(3-(3-כלורו-4-ציאנופניל)-1h-פיראזול-1-יל)פרופאנ-2-איל)- 1h-פיראזול-5-קרבוקסאמיד (2-chloro-4-(1h-pyrazol-5-yl)benzonitrile and (s)-4-(1-(2-aminopropyl)-1h-pyrazol-3-yl)-2-chlorobenzonitrile as intermediates in the process for preparing (s)-3-acetyl-n-(1-(3-(3-chloro-4-cyanophenyl)-1h-pyrazol-1-yl)propan-2-yl)-1h-pyrazole-5-carboxamide) ⤷  Try a Trial
Spain 2486263 ⤷  Try a Trial
New Zealand 598747 ANDROGEN RECEPTOR MODULATING COMPOUNDS ⤷  Try a Trial
Israel 218586 קרבוקסאמידים רב-טבעתיים של אזולים ותכשירי רוקחות המכילים אותם (Polycyclic azole carboxamides and pharmaceutical compositions comprising them) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NUBEQA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2493858 C20200015 00323 Estonia ⤷  Try a Trial PRODUCT NAME: DAROLUTAMIID;REG NO/DATE: EU/1/20/1432 30.03.2020
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
1986495 122019000057 Germany ⤷  Try a Trial 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
2493858 2020018 Norway ⤷  Try a Trial PRODUCT NAME: DAROLUTAMID, EVENTUELT I FORM AV ET FARMASOEYTISK AKSEPTABELT SALT ELLER ESTER DERAV; REG. NO/DATE: EU/1/20/1432/ 20200401
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
2493858 CA 2020 00020 Denmark ⤷  Try a Trial PRODUCT NAME: DAROLUTAMID EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER EN FARMACEUTISK ACCEPTABELT ESTER DERAF; REG. NO/DATE: EU/1/20/1432/001 20200330
>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.