Details for New Drug Application (NDA): 210951

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 eleven 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:	11

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:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Feb 14, 2018	TE:	AB	RLD:	Yes
Patent:	10,052,314	Patent Expiration:	Sep 23, 2033	Product Flag?		Substance Flag?		Delist Request?	Y
Patented Use:	TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
Patent:	10,052,314	Patent Expiration:	Sep 23, 2033	Product Flag?		Substance Flag?		Delist Request?	Y
Patented Use:	TREATMENT IN COMBINATION WITH A GNRH AGONIST OF NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)
Patent:	10,702,508	Patent Expiration:	Apr 30, 2038	Product 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

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