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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Johnson and Johnson
Mallinckrodt
Moodys
AstraZeneca

Last Updated: July 13, 2020

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ERLEADA Drug Profile


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When do Erleada patents expire, and when can generic versions of Erleada launch?

Erleada is a drug marketed by Janssen Biotech and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and seventy-one patent family members in thirty-nine countries.

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

US ANDA Litigation and Generic Entry Outlook for Erleada

Erleada will be eligible for patent challenges on February 14, 2022. 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 June 4, 2033. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ERLEADA
Drug Prices for ERLEADA

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Generic Entry Opportunity Date for ERLEADA
Generic Entry Date for ERLEADA*:
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 ERLEADA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 3
OHSU Knight Cancer InstitutePhase 2
National Cancer Institute (NCI)Phase 2

See all ERLEADA clinical trials

US Patents and Regulatory Information for ERLEADA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 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 ERLEADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 1990032-3 Sweden   Start Trial PRODUCT NAME: APALUTAMIDE; REG. NO/DATE: EU/1/1342 20190116
2368550 2019C/529 Belgium   Start Trial PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACOLOGIQUEMENT ADMISSIBLE DE CELLES-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550 CA 2019 00029 Denmark   Start Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Johnson and Johnson
Mallinckrodt
Moodys
AstraZeneca

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.