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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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 seven 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:7
Generic Entry Opportunity Date for 210951
Generic Entry Date for 210951*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:RLD:Yes
Regulatory Exclusivity Expiration:Feb 14, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 17, 2022
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)
Patent:  Start TrialPatent Expiration:Sep 23, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT IN COMBINATION WITH A GNRH AGONIST OF HIGH RISK NON-METASTATIC, CASTRATION-RESISTANT PROSTATE CANCER (NM-CRPC)

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