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The generic ingredient in LUTATHERA is lutetium dotatate lu-177. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium dotatate lu-177 profile page.
Generic Entry Opportunity Date for 208700
Generic Entry Date for 208700*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
*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: 208700
Profile for product number 001
|Approval Date:||Jan 26, 2018||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Jan 26, 2023|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Jan 26, 2025|
|Regulatory Exclusivity Use:||TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS|
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