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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 213227


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NDA 213227 describes DETECTNET, which is a drug marketed by Radiomedix and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DETECTNET profile page.

The generic ingredient in DETECTNET is copper cu-64 dotatate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the copper cu-64 dotatate profile page.
Summary for 213227
Tradename:DETECTNET
Applicant:Radiomedix
Ingredient:copper cu-64 dotatate
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213227
Generic Entry Date for 213227*:
Constraining patent/regulatory exclusivity:
FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS
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.

Pharmacology for NDA: 213227
Mechanism of ActionPositron Emitting Activity
Suppliers and Packaging for NDA: 213227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DETECTNET copper cu-64 dotatate SOLUTION;INTRAVENOUS 213227 NDA CURIUM US LLC 69945-064 69945-064-01 1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength4mL (1mCi/ML)
Approval Date:Sep 3, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 3, 2027
Regulatory Exclusivity Use:FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS
Regulatory Exclusivity Expiration:Sep 3, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Aug 23, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF CU-64 DOTATATE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS

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