Question 1

Is there a generic for Gallium ga-68 gozetotide?

Accepted Answer

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Gallium ga-68 gozetotide, referencing the brand GOZELLIX. 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 gozetotide?

Accepted Answer

GOZELLIX (NDA 219592, TELIX INNOVATIONS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Gallium ga-68 gozetotide?

Accepted Answer

The Orange Book lists 3 patents against Gallium ga-68 gozetotide products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

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

Accepted Answer

Gallium ga-68 gozetotide is approved in the following dosage forms: powder, solution.

Product	Applicant	Application	TE	Approved
GOZELLIXRLD	TELIX INNOVATIONS	NDA 219592	—	Mar 20, 2025
LOCAMETZRLD	NOVARTIS	NDA 215841	—	Mar 23, 2022
ILLUCCIXRLD	TELIX	NDA 214032	—	Dec 17, 2021
GALLIUM GA 68 GOZETOTIDERLD	UNIV CA LOS ANGELES	NDA 212642	—	Dec 01, 2020
GALLIUM GA 68 GOZETOTIDERLD	UNIV OF CA SAN FRAN	NDA 212643	AP	Dec 01, 2020

Product	Applicant	Application	TE	Approved
GALLIUM GA 68 GOZETOTIDE	RADIOMEDIX	ANDA 216410	AP	Jun 08, 2026
GALLIUM GA-68 GOZETOTIDE	IONETIX	ANDA 219189	AP	May 14, 2026

Patent	Expires	In	Type
11369590	Aug 15, 2028	in 2 yr 2 mo	SubstanceProductU-3400
11027031	Jul 28, 2035	in 9 yr 3 mo	U-3317
12109277	Mar 09, 2036	in 9 yr 10 mo	U-4002

Gallium ga-68 gozetotide

Brand (NDA) products · powder, solution

Generic (ANDA) products (2)

Listed patents (3)

Gallium ga-68 gozetotide — frequently asked questions

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