Regulatory PathRegulatory requirements compared

Active substance

Valaciclovir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Herptrex500 mgFilm-coated tablet · Oral use60 BlisterSAR 381.00Generic · PrescriptionSaudi AmaroxValid
Herptrex500 mgFilm-coated tablet · Oral use10 BlisterSAR 73.40Generic · PrescriptionSaudi AmaroxValid
VALTREX500 mgTablet · Oral use42 BlisterSAR 319.80NCE · PrescriptionGLAXO SAUDI ARABIAValid
VALTREX500 mgTablet · Oral use10 BlisterSAR 86.35NCE · PrescriptionGLAXO SAUDI ARABIAValid
Indications — CHI Daman Drug Formulary

ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; BELL'S PALSY; CHICKENPOX (VARICELLA); HERPES SIMPLEX VIRUS (HERPES LABIALIS); HERPES ZOSTER (SHINGLES); HERPESVIRAL KERATITIS, ZOSTER KERATITIS, KERATITIS, VARICELLA KERATITIS; INFECTIOUS UVEITIS; MULTIPLE MYELOMA

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
VALTREXEQ 500MG BASE; EQ 1GM BASEtablet · oralGLAXOSMITHKLINEPrescription23 Jun 1995
VALTREXEQ 500MG BASE; EQ 1GM BASEtablet · oralGLAXOSMITHKLINEPrescription15 Dec 1995
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralSUN PHARM INDS LTDPrescription31 Jan 2007
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralMYLAN PHARMS INCPrescription24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralRISINGPrescription24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralCHARTWELL RXPrescription24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralAUROBINDO PHARMAPrescription24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralJUBILANT GENERICSPrescription3 Apr 2012
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralHETERO LABS LTD VPrescription8 Apr 2015
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralZYDUS LIFESCIENCESPrescription29 Dec 2017
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralYILINGPrescription18 Mar 2020
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralCIPLADiscontinued24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralAIPING PHARM INCDiscontinued24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralTEVA PHARMSDiscontinued24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralPHARMOBEDIENTDiscontinued24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralHIKMA PHARMSDiscontinued24 May 2010
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralWATSON LABS INCDiscontinued16 Mar 2011
VALACYCLOVIR HYDROCHLORIDEEQ 500MG BASE; EQ 1GM BASEtablet · oralAPOTEXDiscontinued4 Apr 2014

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-VALACYCLOVIR02500582500 MGTABLET · ORALANGITA PHARMA INC.
APO-VALACYCLOVIR02295822500 MGTABLET · ORALAPOTEX INC
APO-VALACYCLOVIR023547051000 MGTABLET · ORALAPOTEX INC
AURO-VALACYCLOVIR02405040500 MGTABLET · ORALAURO PHARMA INC
AURO-VALACYCLOVIR024050591000 MGTABLET · ORALAURO PHARMA INC
JAMP VALACYCLOVIR02440598500 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP VALACYCLOVIR025588581000 MGTABLET · ORALJAMP PHARMA CORPORATION
MYLAN-VALACYCLOVIR023515601000 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-VALACYCLOVIR02351579500 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
NB-VALACYCLOVIR02558130500 MGTABLET · ORALNB PHARMA INC.
PMS-VALACYCLOVIR02298457500 MGTABLET · ORALPHARMASCIENCE INC
PMS-VALACYCLOVIR023812301000 MGTABLET · ORALPHARMASCIENCE INC
PRO-VALACYCLOVIR02315173500 MGTABLET · ORALPRO DOC LIMITEE
RIVA-VALACYCLOVIR02316447500 MGTABLET · ORALLABORATOIRE RIVA INC.
SANDOZ VALACYCLOVIR02347091500 MGTABLET · ORALSANDOZ CANADA INCORPORATED
TEVA-VALACYCLOVIR02357534500 MGTABLET · ORALTEVA CANADA LIMITED
VALACYCLOVIR02442000500 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
VALACYCLOVIR02454645500 MGTABLET · ORALSANIS HEALTH INC
VALACYCLOVIR025195851000 MGTABLET · ORALSANIS HEALTH INC
VALACYCLOVIR025535111000 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
VALTREX02219492500 MGTABLET · ORALGLAXOSMITHKLINE INC
VALTREX022465591000 MGTABLET · ORALGLAXOSMITHKLINE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACVALACYCLOVIR HCL 1 GRAM TABLET$0.41001per EA23 Sep 2026
US NADACVALACYCLOVIR HCL 500 MG TABLET$0.22889per EA23 Sep 2026
US NADACVALTREX 1 GRAM CAPLET$20.244per EA20 May 2026
US NADACVALTREX 500 MG CAPLET$12.80513per EA20 May 2026
NHS Drug TariffValaciclovir 1g tablets£33.9810 tablet1 Oct 2026
NHS Drug TariffValaciclovir 1g tablets£73.4721 tablet1 Oct 2026
NHS Drug TariffValaciclovir 250mg tablets£123.2860 tablet1 Oct 2026
NHS Drug TariffValaciclovir 500mg tablets£8.3510 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 5.1.6.2. Medicines for viral central nervous system infections · core
    Therapeutic equivalent to aciclovir for Zoster; Therapeutic equivalent to aciclovir for Herpes simplex infections; Therapeutic equivalent to aciclovir for Varicella

Safety signals and safety-related labeling changes

All safety entries for valaciclovir →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.