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.
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: | ⤷ Try a Trial | 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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