Is there a generic for Gallium ga-68 gozetotide?

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.

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

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

What patents protect Gallium ga-68 gozetotide?

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.

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

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

FDA Orange Book · active-ingredient family

Gallium ga-68 gozetotide

Gallium ga-68 gozetotide: 5 brands, 2 generics; first approved Dec 01, 2020; generic available.

Generic available

Generic status & protection

Generic available — 2 ANDA applications approved.

Earliest patent expiry Aug 15, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 15, 2028

in 2 yr 1 mo

Originator applications

Brand (NDA) products

GOZELLIXRLDRS

TELIX INNOVATIONSNDA 2195922025

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
N/A	POWDER	INTRAVENOUS	Rx	—

LOCAMETZRLDRS

NOVARTISNDA 2158412022

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
N/A	POWDER	INTRAVENOUS	Rx	—

ILLUCCIXRLDRS

TELIXNDA 2140322021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
N/A	POWDER	INTRAVENOUS	Rx	—

GALLIUM GA 68 GOZETOTIDERLDRS

UNIV CA LOS ANGELESNDA 2126422020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5-5mCi/mL	SOLUTION	INTRAVENOUS	Rx	—

GALLIUM GA 68 GOZETOTIDERLDRS

UNIV OF CA SAN FRANNDA 2126432020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5-5mCi/mL	SOLUTION	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (2)

GALLIUM GA 68 GOZETOTIDE

RADIOMEDIXANDA 2164102026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5-5mCi/ML	SOLUTION	INTRAVENOUS	Rx	AP

GALLIUM GA-68 GOZETOTIDE

IONETIXANDA 2191892026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5-5mCi/mL	SOLUTION	INTRAVENOUS	Rx	AP

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11369590	Aug 15, 2028	in 2 yr 1 mo	SubstanceProductU-3400
11027031	Jul 28, 2035	in 9 yr 2 mo	U-3317
12109277	Mar 09, 2036	in 9 yr 10 mo	U-4002

FDA approval span

Approval history

First approval

Dec 01, 2020

5 yr 8 mo ago

Most recent approval

Jun 08, 2026

1 mo ago

Approvals span 2020–2026 across 7 FDA applications.

Brand (NDA) 571%

Generic (ANDA) 229%

Gallium ga-68 gozetotide — 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.

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