DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203415
, 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 NDA: 203415
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 203415
Suppliers and Packaging for NDA: 203415
||National Drug Code
||Astellas Pharma US, Inc.
||1 BOTTLE in 1 CARTON (0469-0125-99) > 120 CAPSULE in 1 BOTTLE
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Summary for product number 001
|Approval Date:||Aug 31, 2012||TE:||RLD:||Yes|
|Patent:||7,709,517||Patent Expiration:||Aug 13, 2027||Product Flag?||Y||Substance Flag?||Y||Delist Request?||
|Regulatory Exclusivity Expiration:||Aug 31, 2017
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||8,183,274||Patent Expiration:||Aug 24, 2026||Product Flag?||Substance Flag?||Delist Request?||
|Patented Use:||THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).|
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