Data updated: Sep 20, 2026
CAPVAXIVE (pneumococcal 21-valent conjugate vaccine) · Merck
Approved 2024-06-16
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-06-16
- Patent Cliff
- 2036
- Revenue
- $184M (Q2-2026)
- Routes
- Intramuscular
- Dosage Forms
- Injection
CAPVAXIVE Approval History
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Jun 2024 ORIGINAL
Update · CBER biologic (Purple Book)
What CAPVAXIVE Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2024)
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Trial Timeline
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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.
CAPVAXIVE FDA Label Details
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Revenue Insights
- • Q2-2026: $184M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 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.