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Last Updated: June 22, 2021

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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 six patents protecting this drug.

This drug has eighty-five 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:85
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 32
Clinical Trials: 5
Patent Applications: 31
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
Latin American Cooperative Oncology GroupPhase 2
Carolina Urologic Research CenterPhase 3
Alliance Foundation Trials, LLC.Phase 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 Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
>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 2020C/514 Belgium   Try Before You Buy PRODUCT NAME: DAROLUTAMIDE OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1432 20200330
1986495 CA 2020 00009 Denmark   Try Before You Buy PRODUCT NAME: SEDAXAN ELLER EN TAUTOMER DERAF, FLUDIOXONIL OG METALAXYL M; NAT. REG. NO/DATE: 1-235 20191015; FIRST REG. NO/DATE: NL 15544 N 20171229
2493858 LUC00154 Luxembourg   Try Before You Buy 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 301041 Netherlands   Try Before You Buy 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 2090018-9 Sweden   Try Before You Buy 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 122019000057 Germany   Try Before You Buy 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
>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

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