NDAORALTABLET
Approved
Jun 2016
Lifecycle
LOE Approaching
Competitive Pressure
15/100
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 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BYVALSON is a fixed-dose combination oral tablet of nebivolol hydrochloride (beta-blocker) and valsartan (angiotensin II receptor antagonist) approved in 2016 for hypertension and heart failure. It works through multiple mechanisms: decreased heart rate and myocardial contractility via beta-blockade, suppression of renin activity, and vasodilation via angiotensin II receptor blockade. The dual mechanism addresses sympathetic and renin-angiotensin system pathways simultaneously.
LOE Approaching1.4 years to LOE
Product faces patent expiration in ~1.5 years with significant competitive pressure (15 direct competitors), signaling potential team downsizing and transition from growth to defensive positioning.
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.