Gallium ga-68 gozetotide - Generic Drug Details

What are the generic drug sources for gallium ga-68 gozetotide and what is the scope of freedom to operate?

Gallium ga-68 gozetotide is the generic ingredient in three branded drugs marketed by Telix, Novartis, Univ Ca Los Angeles, and Univ Of Ca San Fran, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gallium ga-68 gozetotide has seventy-six patent family members in twenty countries.

Four suppliers are listed for this compound.

Summary for gallium ga-68 gozetotide

International Patents:	76
US Patents:	2
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	3
What excipients (inactive ingredients) are in gallium ga-68 gozetotide?	gallium ga-68 gozetotide excipients list
DailyMed Link:	gallium ga-68 gozetotide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for gallium ga-68 gozetotide

Dosage:

POWDER;INTRAVENOUS

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for gallium ga-68 gozetotide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayo Clinic	Phase 3
Prostate Cancer Foundation	Phase 1/Phase 2
Eli Lilly and Company	Phase 1/Phase 2

See all gallium ga-68 gozetotide clinical trials

Pharmacology for gallium ga-68 gozetotide

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for gallium ga-68 gozetotide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Univ Of Ca San Fran	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212643-001	Dec 1, 2020		RX	Yes	Yes
Univ Ca Los Angeles	GALLIUM GA 68 GOZETOTIDE	gallium ga-68 gozetotide	SOLUTION;INTRAVENOUS	212642-001	Dec 1, 2020		RX	Yes	Yes
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes			Y	Y
Novartis	LOCAMETZ	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	215841-001	Mar 23, 2022		RX	Yes	Yes
Telix	ILLUCCIX	gallium ga-68 gozetotide	POWDER;INTRAVENOUS	214032-001	Dec 17, 2021		RX	Yes	Yes

International Patents for gallium ga-68 gozetotide

Country	Patent Number	Title	Estimated Expiration
Japan	2020073472	ＰＳＭＡ結合性リガンド−リンカー結合体及び使用方法 (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)
European Patent Office	3862026	MONOSACCHARIDE, DISACCHARIDE OU POLYSACCHARIDE UTILISÉ COMME INHIBITEUR DE MÉTAL DANS LA PRÉPARATION DE D'AGENT DE CIBLAGE FONCTIONNALISÉ PAR DU 68GA-CHÉLATE (MONO-, DI- OR POLYSACCHARIDE USED AS METAL INHIBITOR IN THE PREPARATION OF 68GA-CHELATE-FUNCTIONALIZED TARGETING AGENT)
China	104873982	PSMA binding ligand-linker conjugates and methods for using
New Zealand	583931	PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING
Australia	2008289108	PSMA binding ligand-linker conjugates and methods for using
China	106659806	在制备68GA‑螯合物官能化的靶向剂中用作金属抑制剂的单糖、二糖或多糖 (Mono-, di- or polysaccharide used as metal inhibitor in the preparation of 68GA-chelate-functionalized targeting agent)
European Patent Office	3831380	CONJUGUÉS COMPRENANT UN LIGAND DU PSMA ET UN LIEUR ET PROCÉDÉS POUR LEUR UTILISATION (PSMA BINDING LIGAND-LINKER CONJUGATES AND METHODS FOR USING)