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CYTOVENE

NDA

GANCICLOVIR SODIUM | N019661 | CHEPLAPHARM ARZNEIMITTEL GMBH

1 strength0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Navinta LLC - Citizen Petition FDA-2013-P-1061 · 3 docket documents Navinta LLC filed this ANDA Suitability Petition on August 28, 2013, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93, requesting FDA approval to pursue an abbreviated new drug application for Ganciclovir Injection, 500 mg/10 ml solution. The petiti	Other	2013-09-19	Withdrawn	—
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0558 · 3 docket documents Lachman Consultant Services, Inc., filing on behalf of a client, submitted this petition requesting that the FDA Commissioner determine whether Cytovene-IV (Ganciclovir Sodium) for Injection, 500 mg base per vial, approved under NDA 19-661, was voluntarily withdrawn from sale for reasons related to	505(q)	2009-11-22	Withdrawn	—
PharmaForce, Inc. - Citizen Petition FDA-2009-P-0222 · 6 docket documents PharmaForce, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Ganciclovir Sodium Injection, 50 mg/mL, suitable for consideration in an ANDA, with the proposed change being a conversion from the reference listed dr	Other	2009-05-22	Granted	—

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

Clinical Trials

87 trials from ClinicalTrials.gov, 72 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis NCT00002070	Phase 3	Completed	Schering-Plough	—	—
PTH - Preemptive Treatment for Herpesviridae NCT02152358	Phase 4	Completed	Assistance Publique Hopitaux De Marseille	317	2014-02-05 → 2023-04-05
A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis NCT00000698	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	—	— → 2007-08
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus NCT00006340	Phase 1	Completed	Boston Medical Center	—	1994-12 → 2000-07
Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients NCT00373165	Phase 4	Completed	Lower Saxony Center for Nephrology	150	2000-08 → 2003-10
A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy NCT00000673	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	38	— → 1993-05
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation NCT00141037	Phase 1/2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	130	2004-03 → 2010-11
Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)NCT00000136	Phase 3	Completed	Johns Hopkins Bloomberg School of Public Health	234	1990-03 → 1991-10
A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection NCT00000995	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	60	— → 1990-02
Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis NCT02943057	Phase 4	Completed	Singapore National Eye Centre	25	2016-10 → 2024-11-30

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

Medicare Part D Spending

CMS annual spending data for Ganciclovir Sodium (2024)

Total Spending

$64K

Total Claims

131

Beneficiaries

Avg Cost/Unit

$59.53

Spending Trend

$65K(2019)→$111K(2020)→$123K(2021)→$122K(2022)→$61K(2023)→$64K(2024)

YoY Change:+157.0%

5yr CAGR:+58.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Cytovene (2024)

Total Spending

$211K

Total Claims

917

Beneficiaries

186

ASP Price

$39.36

Spending Trend

$536K(2019)→$199K(2020)→$572K(2021)→$388K(2022)→$283K(2023)→$211K(2024)

YoY Change:-4.4%

5yr CAGR:+18.8%

HCPCS: J1570 — Injection, ganciclovir sodium, 500 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain1 active DMF1 inactive

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

EXCELLA GMBH AND CO KGGANCICLOVIR SODIUM

DMF 169922003

HAINAN POLY PHARMACEUTICAL CO LTDInactiveGANCICLOVIR SODIUM

DMF 251222011

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 20, 2020	SUPPL -38	View Letter (PDF)
Jul 5, 2017	SUPPL -36	View Letter (PDF)
Feb 2, 2006	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 23, 1989

No patent or exclusivity listings for this strength.