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Generated: November 19, 2018

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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 one NDA. It is available from one supplier. There are three 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
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 203415
Generic Entry Date for 203415*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Aug 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 13, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Patent:➤ Try a Free TrialPatent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent 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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