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Last Updated: December 1, 2021

DrugPatentWatch Database Preview

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 seven patents protecting this drug.

This drug has ninety-three 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 January 28, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NUBEQA
International Patents:93
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 6
Patent Applications: 35
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
NRG OncologyPhase 3
National Cancer Institute (NCI)Phase 3
University Health Network, TorontoPhase 2

See all NUBEQA clinical trials

US Patents and Regulatory Information for 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 ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NUBEQA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2493858 C02493858/01 Switzerland ⤷  Try it Free PRODUCT NAME: DAROLUTAMIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67521 19.06.2020
2493858 2020/018 Ireland ⤷  Try it Free PRODUCT NAME: DAROLUTAMIDE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/20/1432/001 20200330
1986495 33/2019 Austria ⤷  Try it Free PRODUCT NAME: SEDAXAN ODER EIN TAUTOMER DAVON, FLUDIOXONIL UND METALAXYL M; NAT. REGISTRATION NO/DATE: 3979-0 20181130; FIRST REGISTRATION: NL 29317 20171229
2493858 132020000000064 Italy ⤷  Try it Free PRODUCT NAME: DAROLUTAMIDE(NUBEQA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1432, 20200330
2493858 C20200015 00323 Estonia ⤷  Try it Free PRODUCT NAME: DAROLUTAMIID;REG NO/DATE: EU/1/20/1432 30.03.2020
>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.