Data updated: Nov 8, 2026
Rotateq (rotavirus vaccine, live, oral, pentavalent) · Merck
Approved 2006-02-03
1
Indication
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Prescription
- First Approved
- 2006-02-03
- Revenue
- $134M (Q2-2026)
- Routes
- Oral
- Dosage Forms
- Suspension
Companies
Active Ingredient: Rotavirus Vaccine, Live, Oral, Pentavalent , Rotavirus Vaccine, Live, Oral, Pentavalent
Website: ↗
Rotateq Approval History
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2006 to 2006
Feb 2006 ORIGINAL
Update · CBER biologic (Purple Book)
What Rotateq Treats
1 FDA approvalsOriginally approved for its first indication in 2006 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2006)
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
ENFLONSIA
2025 CLESROVIMAB-CFOR
1 designation
KEYTRUDA QLEX
2025 PEMBROLIZUMAB
1 designation
OHTUVAYRE
2024 ENSIFENTRINE
WINREVAIR
2024 SOTATERCEPT-CSRK
4 designations
VTAMA
2022 TAPINAROF
1 designation
WELIREG
2021 BELZUTIFAN
3 designations
VERQUVO
2021 VERICIGUAT
3 designations
RECARBRIO
2019 CILASTATIN SODIUM
2 designations
PIFELTRO
2018 DORAVIRINE
PREVYMIS
2017 LETERMOVIR
5 designations
STEGLATRO
2017 ERTUGLIFLOZIN
ZEPATIER
2016 ELBASVIR
3 designations
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Clinical Trial Registry
12 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 |
| 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 |
| 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 |
| NCT00880698 results posted | P1072 10638, IMPAACT P1072 | Ph 2 | completed | Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers |
| NCT01341639 results posted | V419-007 2010-021490-37 | Ph 3 | completed | Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007) |
| NCT02193061 | Rota/CeNSIA | Ph 3 | completed | Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs |
| NCT01839175 | HXM01C 2012-005547-24 | Ph 3 | completed | Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination |
| NCT00496054 results posted | V260-021 2007_020 | Ph 3 | completed | Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021) |
| NCT00953056 results posted | V260-028 2009_627 | Ph 1 | completed | A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED) |
| NCT01003431 | V260-036 V260-036 | Ph 3 | withdrawn | A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN) |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
Rotateq FDA Label Details
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Revenue Insights
- • Q2-2026: $134M
- • 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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.