NDAORALTABLET
Approved
Jun 2016
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Data completeness
4/8 — Partial
BYVALSON (nebivolol hydrochloride; valsartan) by AbbVie is established. Approved for hypertension, to lower blood pressure, to lower blood pressure [see clinical studies ( )] and 2 more indications. First approved in 2016.
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYVALSON is a fixed-dose combination of nebivolol (beta-blocker) and valsartan (angiotensin II receptor blocker) indicated for hypertension and heart failure. The dual mechanism decreases heart rate and myocardial contractility via beta-blockade while suppressing renin activity and promoting vasodilation via angiotensin II antagonism. This combination provides complementary blood pressure reduction through sympathetic and renin-angiotensin system pathways.
LOE Approaching11mo to LOE
Product is approaching loss of exclusivity (2027), suggesting downsizing of brand team and shift toward efficiency-focused roles in managed care and generic transition planning.
Mechanism of Action
established. Possible factors that may be involved include: (1) decreased heart rate, (2) decreased myocardial contractility, (3) diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, (4) suppression of renin activity and (5) vasodilation and decreased peripheral…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.