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NUBEQA Drug Profile
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» See Plans and PricingWhen 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
Summary for NUBEQA
| International Patents: | 52 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 27 |
| Clinical Trials: | 4 |
| Patent Applications: | 9 |
| Drug Prices: | Drug price information for NUBEQA |
| DailyMed Link: | NUBEQA at DailyMed |
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 |
|---|---|
| Carolina Urologic Research Center | Phase 3 |
| Alliance Foundation Trials, LLC. | Phase 2 |
| Barbara Ann Karmanos Cancer Institute | Phase 3 |
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 |
International Patents for NUBEQA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 021170 | Start Trial |
| Japan | 2018503662 | Start Trial |
| Brazil | 112012008823 | Start Trial |
| Japan | 2013508447 | Start Trial |
| Hungary | E039390 | Start Trial |
| Israel | 238044 | Start Trial |
| Colombia | 6531494 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
