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Last Updated: October 7, 2024

Details for New Drug Application (NDA): 203415


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NDA 203415 describes XTANDI, which is a drug marketed by Astellas and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XTANDI profile page.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
Summary for 203415
Tradename:XTANDI
Applicant:Astellas
Ingredient:enzalutamide
Patents:3
Suppliers and Packaging for NDA: 203415
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XTANDI enzalutamide CAPSULE;ORAL 203415 NDA Astellas Pharma US, Inc. 0469-0125 0469-0125-99 1 BOTTLE in 1 CARTON (0469-0125-99) / 120 CAPSULE in 1 BOTTLE
XTANDI enzalutamide CAPSULE;ORAL 203415 NDA Astellas Pharma US, Inc. 0469-1125 0469-1125-56 56 CAPSULE in 1 BLISTER PACK (0469-1125-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Aug 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 17, 2026
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE AT HIGH RISK FOR METASTASIS
Patent:⤷  Sign UpPatent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).

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