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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 210951


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NDA 210951 describes ERLEADA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the ERLEADA profile page.

The generic ingredient in ERLEADA is apalutamide. One supplier is listed for this compound. Additional details are available on the apalutamide profile page.
Summary for 210951
Tradename:ERLEADA
Applicant:Janssen Biotech
Ingredient:apalutamide
Patents:12
Suppliers and Packaging for NDA: 210951
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ERLEADA apalutamide TABLET;ORAL 210951 NDA Janssen Products, LP 59676-600 59676-600-12 120 TABLET, FILM COATED in 1 BOTTLE (59676-600-12)
ERLEADA apalutamide TABLET;ORAL 210951 NDA Janssen Products, LP 59676-600 59676-600-56 2 BLISTER PACK in 1 CARTON (59676-600-56) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Feb 14, 2018TE:ABRLD:Yes
Patent:10,702,508Patent Expiration:Apr 30, 2038Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT IN COMBINATION WITH ANDROGEN DEPRIVATION THERAPY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) THAT IMPROVES METASTASIS FREE SURVIVAL
Patent:10,849,888Patent Expiration:Sep 23, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT IN COMBINATION WITH ORCHIECTOMY OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC)
Patent:11,963,952Patent Expiration:Jan 30, 2040Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF METASTATIC CASTRATION SENSITIVE PROSTATE CANCER

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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