You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
AstraZeneca
McKesson
Merck
Dow

Last Updated: March 28, 2020

DrugPatentWatch Database Preview

NUBEQA Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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-one patent family members in thirty-one 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

< Available with Subscription >

  Start Trial

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
Tulane UniversityPhase 3
BayerPhase 3
MANA RBMPhase 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

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.