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Medtronic
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Generated: June 23, 2018

DrugPatentWatch Database Preview

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
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 N 0469-0125-99

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Aug 31, 2012TE:RLD:Yes
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).
Patent:➤ Sign UpPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL

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Daiichi Sankyo
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