TheraRadar
Data updated: May 26, 2026

Varivax (varicella virus vaccine live)

Approved 1995-03-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1995-03-16
Revenue
$594M (Q4-2024)

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Patent cliff and revenue data

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Routes
Subcutaneous, Intramuscular
Dosage Forms
For Injection

Companies

Merck
Active Ingredient: Varicella Virus Vaccine Live , Varicella Virus Vaccine Live

Varivax Approval History

1996
1997
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2005
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2011
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 1995 to 1995
Mar 1995 ORIGINAL
Update · CBER biologic (Purple Book)

What Varivax Treats

1 FDA approvals

Originally approved for its first indication in 1995 .

  • Other (1)
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Clinical Trial Registry

16 trials
Trial Sponsor ID Phase Status Title
NCT06736041 PSK03 U1111-1294-7860 Ph 3 active not recruiting Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT06824194 PSK05 U1111-1295-5983 Ph 3 active not recruiting Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT06824181 PSK00031 U1111-1294-7911 Ph 3 active not recruiting Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age
NCT03621670 results posted 205239 2016-003268-37, V72_57 Ph 3 completed Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
NCT04398706 results posted PSK00008 U1111-1238-1638, PSK00008 Ph 2 completed Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
NCT06314724 PRO-VZV-4006 Ph 3 completed Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines
NCT03691610 results posted MET61 U1111-1205-2836, MET61 Ph 3 completed Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT05422508 MG1111_VAR_P0201 Ph 2 recruiting Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
NCT01049035 results posted MET39 UTN: U1111-1112-2593 Ph 2 completed A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
NCT01681992 results posted 115649 2011-004905-26 Ph 3 completed Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
NCT02184572 results posted 115650 2011-006161-18 Ph 3 completed Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age
NCT01702428 results posted 115648 2011-004891-12 Ph 3 completed Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
NCT03114943 NBP608_VZ_III_2015 Ph 3 completed Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
NCT02367638 MG1111_P1 Ph 1 completed Dose-escalation Phase 1 to Evaluate the Safety and Efficacy of MG1111 in Healthy Adults
NCT03121638 NBP608_VZ_I_2012 Ph 1 completed Safety Study of NBP608 in Healthy Adult Volunteers
NCT03114982 NBP608_VZ_II_2015 Ph 2 completed The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Varivax FDA Label Details

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Revenue Insights

  • • Q4-2024: $594M
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: BLA103552 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.