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Last Updated: September 23, 2021

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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 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 thirty-three patent family members in forty-two 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
Zhujiang HospitalN/A
Coherent Biopharma (Suzhou) Co., Ltd.Phase 1
U.S. Army Medical Research Acquisition ActivityPhase 1

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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Biotech ERLEADA apalutamide TABLET;ORAL 210951-001 Feb 14, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 CA 2019 00029 Denmark ⤷  Try it Free PRODUCT NAME: APALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1342 20190116
2368550 LUC00123 Luxembourg ⤷  Try it Free PRODUCT NAME: APALUTAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/18/1342 20190116
2368550 CR 2019 00029 Denmark ⤷  Try it Free 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:

Dow
AstraZeneca
Harvard Business School
Baxter
Medtronic
Mallinckrodt

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