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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 208700


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NDA 208700 describes LUTATHERA, which is a drug marketed by Aaa Usa Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LUTATHERA profile page.

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.
Summary for 208700
Tradename:LUTATHERA
Applicant:Aaa Usa Inc
Ingredient:lutetium dotatate lu-177
Patents:2
Generic Entry Opportunity Date for 208700
Generic Entry Date for 208700*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700 NDA Advanced Accelerator Applications USA, Inc 69488-003 69488-003-01 1 VIAL in 1 PACKAGE (69488-003-01) > 20.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10mCi/ML
Approval Date:Jan 26, 2018TE: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
Patent:  Start TrialPatent Expiration:Jul 25, 2038Product Flag?YSubstance Flag?Delist Request?

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