Viewing data from:

GALZIN

NDA

ZINC ACETATE | N020458 | ETON PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Eton Pharmaceuticals, Inc. FDA-2025-P-2444 · 21 docket documents Eton Pharmaceuticals, Inc. filed this citizen petition on July 16, 2025 under Section 505 of the FDCA requesting that the FDA refuse to approve any ANDA or 505(b)(2) application using Galzin (zinc acetate) oral capsules at 25 mg and 50 mg as the reference listed drug unless bioequivalence is demonst	505(q)	2025-07-17	Open	Eton Pharmaceuticals, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

155 trials from ClinicalTrials.gov, 124 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Therapeutic Zinc in Infant Bacterial Illness NCT00347386	Phase 2/3	Completed	Centre For International Health	700	2005-07 → 2008-12
Zinc Resistant Starch Project NCT01811836	N/A	Completed	Washington University School of Medicine	20	2013-03 → 2013-07
Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers NCT02868151	Phase 2/3	Completed	Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre	180	2016-08 → 2018-10
Zinc & Bone Health in Thalassemia: The Think Zinc Study NCT00459732	N/A	Completed	UCSF Benioff Children's Hospital Oakland	45	2006-04 → 2011-02
Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus NCT03112382	Phase 4	Completed	Cairo University	80	2015-11 → 2017-05
VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE NCT02248584	N/A	Completed	University of Campinas, Brazil	60	2011-01 → 2011-12
IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity NCT02609386	Phase 2	Completed	Brooklyn ImmunoTherapeutics, LLC	105	2016-01-11 → 2022-02-28
Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth NCT03406793	N/A	Completed	UCSF Benioff Children's Hospital Oakland	2,886	2018-02-20 → 2020-01-12
Age-Related Eye Disease Study (AREDS)NCT00000145	Phase 3	Completed	National Eye Institute (NEI)	4,757	1990-09 → 2006-12
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine NCT00000635	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	25	— → 1992-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$460.52

Highest Price

$8408.87

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
57844-0215-52GALZIN	$497.74	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
57844-0215-52GALZIN	$460.52	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
57844-0208-52GALZIN	$829.48	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
57844-0208-52GALZIN	$765.61	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
71863-0124-25GALZIN 25MG CAP	$8408.87	FSS	Eton Pharmaceuticals, Inc	07/31/2026
71863-0124-25GALZIN 25MG CAP	$5795.46	Big4	Eton Pharmaceuticals, Inc	07/31/2026
71863-0125-25GALZIN 50MG CAP	$8408.87	FSS	Eton Pharmaceuticals, Inc	07/31/2026
71863-0125-25GALZIN 50MG CAP	$5581.91	Big4	Eton Pharmaceuticals, Inc	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

GLOBAL CALCIUM PRIVATE LTDZINC ACETATE USP

DMF 368722022

SICHUAN XIN KAI YUAN PHARMACEUTICAL CO LTDZINC ACETATE

DMF 428762025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 26, 2024	SUPPL -9	View Letter (PDF)
Mar 14, 2002	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 25MG ZINC

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 28, 1997

No patent or exclusivity listings for this strength.

#002 — EQ 50MG ZINC

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jan 28, 1997