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NDA

GANCICLOVIR | N020569 | BAUSCH AND LOMB INC

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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Cytovene-IV (Ganciclovir Sodium) for Injection, 500 mg base per vial, approved under NDA 19-661, was voluntarily withdrawn from sale for reasons related to	505(q)	2009-11-22	Withdrawn	—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.

API Supply Chain4 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

EXCELLA GMBH AND CO KGGANCICLOVIR

DMF 155672001

TRIFARMA SPAGANCICLOVIR, USP

DMF 237212010

SHANGHAI PHARMA GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDGANCICLOVIR

DMF 289732015

APITORIA PHARMA PRIVATE LTDGANCICLOVIR USP

DMF 314022017

RANBAXY LABORATORIES LTDInactiveGANCICLOVIR

DMF 160432002

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGANCICLOVIR (INTERMEDIATE DRUG SUBSTANCE)

DMF 190492005

EXCELLA GMBHInactiveGANCICLOVIR ANHYDROUS R

DMF 243372010

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveGANCICLOVIR USP (NON-STERILE API)

DMF 271332013

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

Products (1)

#001 — 4.5MG

0 patents0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: Mar 4, 1996

No patent or exclusivity listings for this strength.