Details for New Drug Application (NDA): 213227
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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 Action | Positron 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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 4mL (1mCi/ML) | ||||
Approval Date: | Sep 3, 2020 | TE: | 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 Up | Patent Expiration: | Aug 23, 2032 | Product 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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