NDAINTRAVENOUSSOLUTION
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
2/8 — Basic
GALLIUM GA 68 EDOTREOTIDE (edotreotide gallium ga-68) by Imagin Medical is 68 dotatoc binds to somatostatin receptors, with highest affinity (k i = 2. First approved in 2019.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GALLIUM GA 68 EDOTREOTIDE (68Ga-DOTATOC) is a positron emission tomography (PET) imaging agent that binds with high affinity to somatostatin receptor subtype 2 (sstr2), which is overexpressed on neuroendocrine tumor cells. It is used for diagnostic imaging of somatostatin receptor-positive neuroendocrine tumors. The gallium-68 radionuclide emits positrons that enable real-time tumor localization and staging.
LOE Approaching4mo to LOE
The product is nearing loss of exclusivity (August 2026) with modest competitive pressure (30), suggesting the commercial team may be rightsizing ahead of generic competition.
Mechanism of Action
68 DOTATOC binds to somatostatin receptors, with highest affinity (K i = 2.5± 0.5 nanomolar) for subtype 2 receptors (sstr2). Ga 68 DOTATOC binds to cells that express somatostatin receptors including malignant neuroendocrine cells, which overexpress sstr2 receptors. Gallium 68 is a β+ emitting…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on GALLIUM GA 68 EDOTREOTIDE offers exposure to specialized diagnostic imaging and nuclear medicine markets, but the product's imminent LOE (0.3 years remaining) means roles are focused on defending current market share rather than growth. Career mobility is recommended for those seeking long-term brand development opportunities.
Diagnostic Imaging Specialist
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.