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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Fuji
Cipla
Farmers Insurance
Merck
Harvard Business School
Cerilliant
Argus Health
Daiichi Sankyo

Generated: December 13, 2017

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:1
Applicant:1
Ingredient:1
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 0469-0125-99 1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Aug 31, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 31, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 10, 2017
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-REISISTANT PROSTATE CANCER (CRPC)
Patent:► SubscribePatent Expiration:Aug 13, 2027Product Flag?YSubstance Flag?YDelist Request?


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Serving leading biopharmaceutical companies globally:

Accenture
Cipla
Mallinckrodt
US Army
Citi
Novartis
Express Scripts
Farmers Insurance
McKesson
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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