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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.
Generic Entry Opportunity Date for 203415
*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.
Profile for product number 001
|Approval Date:||Aug 31, 2012||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Dec 16, 2022|
|Regulatory Exclusivity Use:||TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC)|
|Regulatory Exclusivity Expiration:||Jul 13, 2021|
|Regulatory Exclusivity Use:||TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER|
|Patent:||Start Trial||Patent Expiration:||Aug 13, 2027||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
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