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
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 |


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
Sponsor | Phase |
---|---|
AstraZeneca | Phase 1/Phase 2 |
NRG Oncology | Phase 3 |
National Cancer Institute (NCI) | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for NUBEQA
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 |