Orange Book product · Brand (NDA)

GOZELLIX

GALLIUM GA-68 GOZETOTIDE

Brand (NDA)NDA 219592RX TELIX INNOVATIONS

Mar 20, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 20, 2025
1 yr 3 mo ago
Today
Patent 11027031 expires
Listed method-of-use patent (U-3317) expiration.
Jul 28, 2035
in 9 yr 3 mo

Active ingredient

GALLIUM GA-68 GOZETOTIDE

Strength

N/A

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 219592

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11027031	Jul 28, 2035	in 9 yr 3 mo	U-3317