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Last Updated: November 29, 2022

Apalutamide - Generic Drug Details


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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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Apalutamide has two hundred and fifty patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for apalutamide
Recent Clinical Trials for apalutamide

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
Edwin Posadas, MDPhase 2
Enviro Therapeutics, Inc.Phase 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 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Supplementary Protection Certificates for apalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 C02368550/01 Switzerland See Plans and Pricing PRODUCT NAME: APALUTAMID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67072 19.09.2019
3533792 CA 2021 00041 Denmark See Plans and Pricing PRODUCT NAME: APALUTAMID; REG. NO/DATE: EU/1/18/1342 20190116
2368550 300993 Netherlands See Plans and Pricing PRODUCT NAME: APALUTAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1342 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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