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Last Updated: April 9, 2025

Claims for Patent: 12,102,696

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Summary for Patent: 12,102,696

Title:	Radiolabeling and formulation for scale up of 64Cu-DOTATATE
Abstract:	The present disclosure relates to methods to create a robust procedure capable of supplying commercial quantities of a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.
Inventor(s):	David Pipes, Lauren Radford, Shaun Loveless, Allan Casciola
Assignee:	Curium US LLC
Application Number:	US17/467,110
Patent Claims:	1. A drug product for use in positron emission tomography comprising 64Cu-DOTATATE (64Cu—N-[(4,7,10-tricarboxymethyl-1,4,7,10-tetrazacyclododec-1-yl)acetyl]-(D)-phenylalanyl-(L)-cysteinyl-(L)-tyrosyl-(D)-tryptophanyl-(L)-lysyl-(L)-threoninyl-(L)-cysteinyl-(L)-threonine-cylcic disulfide (Cys2-Cys7)), wherein the drug product comprises a molar ratio of total DOTATATE:total 64Cu of about 125:1 to about 1:1 and is a single-dose vial containing 148 MBq (4 mCi) of 64Cu-DOTATATE at calibration date and time in a 4 mL solution volume, wherein the radiochemical purity of the drug product is ≥96%. 2. The drug product of claim 1, wherein the radiochemical purity of the drug product is ≥97%. 3. The drug product of claim 1, wherein the radiochemical purity of the drug product is ≥98%. 4. The drug product of claim 1, wherein the radiochemical purity of the drug product is ≥99%. 5. The drug product of claim 1, wherein the drug product is stable for 48 hours after formulation. 6. The drug product of claim 1, wherein the drug product is stable for 24 hours after formulation. 7. The drug product of claim 1, wherein the molar ratio of total DOTATATE:total 64Cu is about 125:1 to about 75:1.

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