Gallium ga-68 edotreotide
Gallium ga-68 edotreotide: 1 brand, 1 generic; first approved Aug 21, 2019; generic available.
Generic available: 1 ANDA application approved.
Brand (NDA) products
- GALLIUM GA 68 EDOTREOTIDERLDRSUIHC PET IMAGINGNDA 2108282019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5-4mCi/ML SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (1)
- GALLIUM GA 68 EDOTREOTIDEMETHODISTANDA 2188452025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5-4mCi/ML SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Marketing exclusivity
- ODE-383Orphan-drug exclusivity (7 years)
2 mo ago
- WExclusivity withdrawal / change
2 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2019–2025 across 2 FDA applications.
Gallium ga-68 edotreotide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
