Orange Book product · Brand (NDA)

LOCAMETZ

GALLIUM GA-68 GOZETOTIDE

Brand (NDA)NDA 215841RX NOVARTIS

Mar 23, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 23, 2022
4 yr 4 mo ago
Today
Patent 11369590 expires
Listed drug substance patent expiration.
Aug 15, 2028
in 2 yr 2 mo
Patent 12109277 expires
Listed method-of-use patent (U-4002) expiration.
Mar 09, 2036
in 9 yr 10 mo

Active ingredient

GALLIUM GA-68 GOZETOTIDE

Strength

N/A

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215841

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
11369590	Aug 15, 2028	in 2 yr 2 mo	SubstanceProductU-3400
12109277	Mar 09, 2036	in 9 yr 10 mo	U-4002