You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 21, 2024

Apalutamide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for apalutamide and what is the scope of freedom to operate?

Apalutamide is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apalutamide has two hundred and sixty-five patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for apalutamide
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for apalutamide
Generic Entry Date for apalutamide*:
Constraining patent/regulatory exclusivity:
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 apalutamide

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

SponsorPhase
Prostate Cancer FoundationPhase 2
Merck Sharp & Dohme LLCPhase 2
University of CincinnatiPhase 2

See all apalutamide clinical trials

Paragraph IV (Patent) Challenges for APALUTAMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ERLEADA Tablets apalutamide 60 mg 210951 5 2022-02-14

US Patents and Regulatory Information for apalutamide

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 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-002 Feb 17, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for apalutamide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Erleada apalutamide EMEA/H/C/004452
Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Authorised no no no 2019-01-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for apalutamide

Country Patent Number Title Estimated Expiration
Japan 5133975 ⤷  Try a Trial
Lithuania 3533792 ⤷  Try a Trial
Croatia P20201721 ⤷  Try a Trial
Poland 2858985 ⤷  Try a Trial
Guatemala 201500071 ANTIANDRÒGENOS PARA EL TRATAMIENTO DEL CANCER DE PROSTATA RESIDENTE A LA CASTRACION NO METASTÀSICO3 ⤷  Try a Trial
Eurasian Patent Organization 201890598 АНТИАНДРОГЕНЫ ДЛЯ ЛЕЧЕНИЯ НЕМЕТАСТАТИЧЕСКОГО КАСТРАЦИОННО-РЕЗИСТЕНТНОГО РАКА ПРОСТАТЫ ⤷  Try a Trial
Denmark 2368550 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for apalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3533792 132021000000170 Italy ⤷  Try a Trial PRODUCT NAME: APALUTAMIDE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116
2368550 C201930040 Spain ⤷  Try a Trial PRODUCT NAME: APALUTAMIDA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1342; DATE OF AUTHORISATION: 20190114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1342; DATE OF FIRST AUTHORISATION IN EEA: 20190114
2368550 122019000060 Germany ⤷  Try a Trial PRODUCT NAME: APALUTAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1342 20190114
3533792 PA2021525 Lithuania ⤷  Try a Trial PRODUCT NAME: APALUTAMIDAS; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550 CR 2019 00029 Denmark ⤷  Try a Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550 PA2019512,C2368550 Lithuania ⤷  Try a Trial PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
2368550 PA2019512 Lithuania ⤷  Try a Trial PRODUCT NAME: APALUTAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1342 20190114
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.