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Last Updated: November 25, 2020

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Apalutamide - Generic Drug Details

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What are the generic sources for apalutamide and what is the scope of patent protection?

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

Apalutamide has one hundred and seventy-four patent family members in thirty-nine 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
Janssen-Cilag Ltd.Phase 3
ECOG-ACRIN Cancer Research GroupPhase 3
Zenith EpigeneticsPhase 2

See all apalutamide clinical trials

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   Start Trial   Start Trial   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes   Start Trial   Start Trial 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
>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 apalutamide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2368550 CR 2019 00029 Denmark   Start Trial PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/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
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 132019000000084 Italy   Start Trial PRODUCT NAME: APALUTAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ERLEADA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1342, 20190116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Johnson and Johnson
Mallinckrodt
Merck
Moodys

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