Data updated: May 26, 2026
BYVALSON (nebivolol hydrochloride)
Cardiovascular
Approved 2016-06-03
1
Indication
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-06-03
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET
BYVALSON Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2016 to 2023
What BYVALSON Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
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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.
BYVALSON FDA Label Details
View full patent landscape →
2 OB patents · 2 families ·
24 international docs across 13 countries
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 2 active patents
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.