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Details for Generic Name: acyclovir

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Acyclovir is the generic ingredient in six branded drugs marketed by Actavis Elizabeth, Apotex Inc, Cadila Pharms Ltd, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Stason, Teva, Teva Pharms, Watson Labs, Delcor Asset, Valeant Bermuda, Amneal Pharms, Mylan Pharms Inc, Actavis Mid Atlantic, Hi Tech Pharma, Innocutis Holdings, Carlsbad, Hetero Labs Ltd V, Zydus Pharms Usa Inc, Abbvie, Hikma Maple , Apothecon, Aurobindo Pharma Ltd, Bedford, Fresenius Kabi Usa, Hospira, Teva Parenteral, and Glaxosmithkline, and is included in fifty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifty-two drug master file entries for acyclovir. Ten suppliers are listed for this compound.

Summary for Generic Name: acyclovir

Tradenames:6
Patents:6
Applicants:33
NDAs:59
Drug Master File Entries: see list52
Suppliers: see list10
Therapeutic Class:Antivirals

Clinical Trials for: acyclovir

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV
Status: Completed Condition: Genital Herpes; HIV Infection

Effect of Body Mass on Acyclovir Pharmacokinetics
Status: Active, not recruiting Condition: Hematological Malignancy; Pharmacokinetics of Acyclovir

HSV-2 Shedding Resolution After Acyclovir Treatment
Status: Completed Condition: Genital Herpes

Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda
Status: Completed Condition: HIV Infections; Herpes Genitalis

Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
Status: Completed Condition: Genital Herpes

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation
Status: Active, not recruiting Condition: Genital Herpes

Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
Status: Completed Condition: Herpes Simplex

Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates
Status: Completed Condition: Herpes Simplex

Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2)
Status: Completed Condition: HIV Infections; Herpesvirus 2, Human

Valacyclovir vs. Acyclovir as HSV-2 Suppressive Therapy: Effect on Plasma HIV-1 Levels Among HIV-1/HSV-2 Co-infected Persons
Status: Completed Condition: HSV Infection; HIV Infection

Acyclovir Therapy for Genital Herpes Ulcers in HIV Negative African Women
Status: Completed Condition: Ulcers of Female Genital Organs

Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
Status: Completed Condition: Herpes Labialis

Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
Status: Recruiting Condition: Herpes Zoster

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes
Status: Completed Condition: HIV Infections; HIV Seronegativity; Herpes Genitalis

Efficacy of Antiviral Medications in Controlling Vertigo Attacks of Patients With Meniere's Disease
Status: Recruiting Condition: Meniere's Disease

A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo)
Status: Completed Condition: Herpes Simplex Virus; Neonatal Sepsis

A Randomized Controlled Trial of Acyclovir Among HIV and HSV-2 Co-Infected Women, Chiang Rai, Thailand
Status: Completed Condition: HIV; Herpes

GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
Status: Completed Condition: Genital Herpes

Iontophoretic Application of Acyclovir Cream to Treat Recurrent Herpes Labialis
Status: Completed Condition: Herpes Labialis

Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon
Status: Completed Condition: HIV-1 and HSV-2 Coinfection; HIV Infections

PTH - Preemptive Treatment for Herpesviridae
Status: Recruiting Condition: Viral Pneumonia

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
Status: Recruiting Condition: GENITAL HERPES

Episodic Acyclovir Therapy for Genital Ulcers
Status: Completed Condition: HIV Infections; Ulcer; Herpes Simplex

Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients
Status: Completed Condition: HIV Infections; Chickenpox

Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)
Status: Completed Condition: Leukoplakia, Hairy; HIV Infections

Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir
Status: Completed Condition: Herpes Simplex; HIV Infections

A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems
Status: Completed Condition: HIV Infections; Chickenpox

A Study of Zidovudine Plus Acyclovir in HIV-Infected Patients
Status: Completed Condition: HIV Infections

The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
Status: Completed Condition: Herpes Simplex; HIV Infections

A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
Status: Completed Condition: Herpes Simplex; HIV Infections

A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
Status: Completed Condition: Herpes Simplex; HIV Infections

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
Status: Completed Condition: Herpes Simplex

Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Status: Completed Condition: Cytomegalovirus Retinitis; HIV Infections

A Multicenter, Double Blind, Comparative Study of Zidovudine Alone Versus Zidovudine and Acyclovir as Treatment for HIV-Infected Patients With CD4+ Counts Less Than 200 Cells/mm3
Status: Completed Condition: HIV Infections

Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)
Status: Completed Condition: Herpes Simplex; HIV Infections

Iontophoretic Application of Acyclovir Gel to Treat Cold Sores
Status: Completed Condition: Herpes Labialis

Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Status: Completed Condition: Herpes Labialis

The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
Status: Completed Condition: HIV Infections

Bioequivalence of Two Formulations of Acyclovir
Status: Completed Condition: Healthy

Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients
Status: Completed Condition: Herpes Labialis

Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
Status: Completed Condition: Herpes Labialis

Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis
Status: Completed Condition: Herpes Labialis

Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission
Status: Completed Condition: HIV Infection; Herpes Simplex, Genital; Sexually Transmitted Diseases

Long-Term Oral Acyclovir Usage to Prevent Herpes Zoster Virus Infection After Bone Marrow Transplant
Status: Completed Condition: VZV Infection After Bone Marrow Transplantation

A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC
Status: Not yet recruiting Condition: Articular Cartilage Defect

Contribution of Salivary Cortisol in the Detection of Infra-clinic Cortisol Adenoma (ACIC)
Status: Terminated Condition: Obesity

An Open, Multicenter Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Status: Completed Condition: Herpes Simplex; HIV Infections

Cytomegalovirus Control in Critical Care
Status: Recruiting Condition: Critical Illness

Efficacy and Safety of Foscarnet Sodium and Sodium Chloride Injection in Patients With Herpes Zoster
Status: Not yet recruiting Condition: Herpes Zoster

Phase 3 Clinical Study for the Treatment of Cold Sore
Status: Completed Condition: Herpes Labialis

Class 3 Biowaivers
Status: Completed Condition: Healthy

Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection
Status: Completed Condition: Herpes Simplex

Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
Status: Active, not recruiting Condition: Bone Marrow Transplantation; Cytomegalovirus

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System
Status: Recruiting Condition: Herpes Simplex

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
Status: Completed Condition: Herpes Simplex

Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
Status: Completed Condition: Herpes Simplex

Comparison of Topical Antiviral Agents for Labial Cold Sores (Herpes Labialis)
Status: Not yet recruiting Condition: Reccurent Herpes Labialis

Effect of HSV-2 Suppressive Therapy on Sexual Behavior
Status: Active, not recruiting Condition: Genital Herpes

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Status: Completed Condition: Herpes Simplex; HIV Infections

SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir
Status: Completed Condition: Herpes Simplex; HIV Infections

An Open Study of Foscarnet Treatment of Acyclovir-Resistant Herpes Simplex Virus in Patients With the Acquired Immunodeficiency Syndrome and Other Immunodeficiencies
Status: Completed Condition: Herpes Simplex; HIV Infections

An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Status: Completed Condition: Herpes Labialis

The Pilot Study of Foscarnet Cream in the Treatment of Mucocutaneous Herpes Simplex Virus Infections in Immunocompromised Patients Unresponsive to Acyclovir Treatment
Status: Completed Condition: Herpes Simplex; HIV Infections

Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS
Status: Completed Condition: Herpes Simplex; HIV Infections

Advanced Cardiovascular Imaging Consortium
Status: Completed Condition: Chest Pain; Coronary Occlusion; Coronary Artery Disease

Comparative Safety and Efficacy of Two Antiviral Treatments in the Treatment of Recurrent Herpes Simplex Labialis
Status: Recruiting Condition: Herpes Labialis

A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients
Status: Completed Condition: Cytomegalovirus Infections; HIV Infections

Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis
Status: Completed Condition: Herpes Labialis

A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Status: Recruiting Condition: Progressive Multiple Sclerosis

Pharmacokinetic Interaction Study of Steady-state Tipranavir/Ritonavir (TPV/r) With Single-dose Valaciclovir (VAL) in Healthy Volunteers
Status: Completed Condition: Healthy

Valacyclovir 1000 mg Tablet Under Fed Conditions
Status: Completed Condition: Healthy

Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those With KRAS G12D
Status: Active, not recruiting Condition: Non-Small Cell Lung Cancer

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment
Status: Recruiting Condition: Metastatic Castration-resistant Prostate Cancer

Herpetic Eye Disease Study (HEDS) II
Status: Completed Condition: Keratitis, Herpetic; Ocular Herpes Simplex; Herpes Simplex

Herpetic Eye Disease Study (HEDS) I
Status: Active, not recruiting Condition: Keratitis, Herpetic; Ocular Herpes Simplex

Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
Status: Completed Condition: Cancer

Evaluation Of Valaciclovir In Patients With Chickenpox
Status: Completed Condition: Varicella

Anti-Herpetic Treatment of Genital Ulcer : Effect on HIV & Herpes Shedding (ANRS 1212)
Status: Completed Condition: Ulcer; Herpes Genitalis

Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir
Status: Completed Condition: Encephalitis

Clinical Assessment of the Effectiveness and Safety of Herpes Patch SOS in the Treatment of Herpes Simplex Labialis in Comparison to a Competitor's Product.
Status: Completed Condition: Herpes Simplex Labialis

A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
Status: Completed Condition: Herpes Simplex

Antimicrobial PK in Infants With Suspected or Confirmed Infection
Status: Completed Condition: Infection

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults
Status: Completed Condition: Kidney Transplantation; Kidney Disease

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Status: Completed Condition: Acute Undifferentiated Leukemia; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; L1 Adult Acute Lymphoblastic Leukemia; L1 Childhood Acute Lymphoblastic Leukemia; L2 Adult Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia; Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
Status: Recruiting Condition: Relapsing-remitting Multiple Sclerosis

Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir
Status: Suspended Condition: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection

Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?
Status: Recruiting Condition: HIV Infections; Herpes Simplex

The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
Status: Withdrawn Condition: Herpes Simplex; HIV Infections; Chickenpox

A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)
Status: Not yet recruiting Condition: Herpes Simplex Virus

A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients
Status: Completed Condition: Genital Herpes; Herpes Genitalis

Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?
Status: Recruiting Condition: HIV Infection; Herpes Simplex Type II; HIV Infections

Palatability Testing of a New Paediatric Formulation of Valacyclovir
Status: Suspended Condition: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection

Pharmacokinetic Study Of Valaciclovir Hydrochloride Tablets
Status: Completed Condition: Renal Impairment

Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia
Status: Active, not recruiting Condition: Waldenstrom's Macroglobulinemia

Valacyclovir in Immunocompromised Children
Status: Completed Condition: Shingles; Bone Marrow Transplantation

An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
Status: Completed Condition: HIV Infections

PACT for Individuals With Serious Mental Illness
Status: Not yet recruiting Condition: Schizophrenia and Disorders With Psychotic Feature

The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
Status: Completed Condition: Diabetes

A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children With Immunodeficiency Syndromes
Status: Completed Condition: HIV Infections; Immunologic Deficiency Syndromes; Lymphoproliferative Disorders

Phase II Study of Subcutaneous (SC) Bortezomib, Lenalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma; Followed by SC Bortezomib Maintenance
Status: Withdrawn Condition: Multiple Myeloma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
ACYCLOVIR SODIUM
acyclovir sodium
INJECTABLE;INJECTION074720Apr 22, 1997DISCNNo<disabled><disabled>
Glaxosmithkline
ZOVIRAX
acyclovir sodium
INJECTABLE;INJECTION018603Aug 30, 1983DISCNNo<disabled><disabled>
Dava Pharms Inc
ACYCLOVIR
acyclovir
CAPSULE;ORAL074872Apr 22, 1997DISCNNo<disabled><disabled>
Teva
ACYCLOVIR
acyclovir
CAPSULE;ORAL074828Apr 22, 1997DISCNNo<disabled><disabled>
Watson Labs
ACYCLOVIR
acyclovir
CAPSULE;ORAL075101Apr 15, 1998DISCNNo<disabled><disabled>
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