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ZOVIRAX

NDA

ACYCLOVIR | N020089 | PHARMOBEDIENT CONSULTING LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain21 active DMFs15 inactive

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

QUIMICA SINTETICA SAACYCLOVIR

DMF 85841990

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAACYCLOVIR

DMF 100441993

OLON SPAACYCLOVIR

DMF 106851994

YUNG ZIP CHEMICAL IND CO LTDACYCLOVIR

DMF 108301994

UNION QUIMICO FARMACEUTICA SA (UQUIFA)ACYCLOVIR

DMF 118961996

MATRIX PHARMACORP PRIVATE LTDACYCLOVIR USP

DMF 132771998

TEVA PHARMACEUTICAL INDUSTRIES LTDACYCLOVIR

DMF 161442002

YUNG ZIP CHEMICAL IND CO LTDACYCLOVIR (PROCESS II)

DMF 199482006

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDACYCLOVIR USP (API)

DMF 202032007

OLON SPAACYCLOVIR

DMF 204452007

SIGNA SA DE CVACYCLOVIR USP

DMF 229492009

HUBEI YITAI PHARMACEUTICAL CO LTDACYCLOVIR (NON-STERILE, BULK FORM)

DMF 249192011

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDACYCLOVIR USP

DMF 249342011

PIRAMAL PHARMA LTDACYCLOVIR

DMF 253892011

HETERO DRUGS LTDACYCLOVIR

DMF 255872011

AURORE LIFE SCIENCES PRIVATE LTDACYCLOVIR USP

DMF 345162020

HAINAN POLY PHARM CO LTDACYCLOVIR SODIUM DIHYDRATE DRUG SUBSTANCE

DMF 351122020

ZHEJIANG ZHEBEI PHARMACEUTICAL CO LTDACYCLOVIR

DMF 360712021

AURORE LIFE SCIENCES PRIVATE LTDACYCLOVIR USP [SITE KHAZIPALLY]

DMF 363282021

ATUL BIOSCIENCE LTDACYCLOVIR USP

DMF 415842025

APEX HEALTHCARE LTDACYCLOVIR USP

DMF 420672025

LACHEMA BRNOInactiveACYCLOVIR

DMF 95301992

OMNICHEM SAInactiveACYCLOVIR

DMF 101241993

CIPLA LTDInactiveACYCLOVIR

DMF 107101994

LEK LJUBLJANA PHARMACEUTICAL AND CHEMICAL COInactiveACYCLOVIR ACTIVE SUBSTANCE

DMF 113521995

FIDIA FARMACEUTICI SPAInactiveACYCLOVIR SODIUM SALT

DMF 118291996

ISTITUTO BIOLOGICO CHEMIOTERAPICO SPA DIVISIONE UNIBIOSInactiveACYCLOVIR

DMF 119811996

RANBAXY INCInactiveACYCLOVIR DRUG SUBSTANCE

DMF 121591996

TEVA GROUPInactiveACYCLOVIR USP

DMF 122091996

MALLINCKRODT CHEMICAL INCInactiveACYCLOVIR USP (MICRONIZED), CODED 2524

DMF 126211997

TEVA GROUPInactiveACYCLOVIR USP

DMF 146541999

SAMCHULLY PHARMACEUTICAL CO LTDInactiveACYCLOVIR DRUG SUBSTANCE

DMF 148652000

ASTRA IDL LTDInactiveACYCLOVIR USP, BULK

DMF 150992000

LIVZON GROUP CHANGZHOU KONY PHARMACEUTICAL CO LTDInactiveACYCLOVIR

DMF 175812004

QIDONG DONGYUE PHARMACEUTICAL CO LTDInactiveACYCLOVIR

DMF 266592012

PHARMACEUTICAL WORKS POLPHARMA SAInactiveACYCLOVIR

DMF 267872013

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 13, 2025	SUPPL -21	View Letter (PDF)
Aug 13, 2008	SUPPL -20	View Letter (PDF)
Dec 15, 2005	SUPPL -19	View Letter (PDF)
May 27, 2004	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Apr 30, 1991

No patent or exclusivity listings for this strength.

#002 — 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 30, 1991