Question 1

Is there a generic for Gallium ga-68 edotreotide?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Gallium ga-68 edotreotide, referencing the brand GALLIUM GA 68 EDOTREOTIDE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Gallium ga-68 edotreotide?

Accepted Answer

GALLIUM GA 68 EDOTREOTIDE (NDA 210828, UIHC PET IMAGING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Gallium ga-68 edotreotide have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Gallium ga-68 edotreotide. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Gallium ga-68 edotreotide are approved?

Accepted Answer

Gallium ga-68 edotreotide is approved in the following dosage form: solution.

Gallium ga-68 edotreotide

Brand (NDA) products · solution

Generic (ANDA) products (1)

Marketing exclusivity (2)

Listed patents

Gallium ga-68 edotreotide — frequently asked questions

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