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Last Updated: July 4, 2020

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NUBEQA Drug 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 four patents protecting this drug.

This drug has fifty-two patent family members in thirty-two countries.

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

US ANDA Litigation and 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
Drug patent expirations by year for NUBEQA
Drug Prices for NUBEQA

See drug prices for NUBEQA

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
Carolina Urologic Research CenterPhase 3
Alliance Foundation Trials, LLC.Phase 2
Barbara Ann Karmanos Cancer InstitutePhase 3

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   Start Trial   Start Trial Y Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 CA 2020 00020 Denmark   Start 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
2493858 301041 Netherlands   Start Trial 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 LUC00154 Luxembourg   Start 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
>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.