NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Sep 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
AMLODIPINE BESYLATE (amlodipine besylate) by Accord Biopharma is (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. First approved in 2007.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Amlodipine besylate is a calcium channel antagonist (dihydropyridine) oral tablet approved in 2007 for hypertension and angina. It works by inhibiting transmembrane calcium ion influx into vascular smooth muscle and cardiac muscle, reducing peripheral vascular resistance and blood pressure. The drug is indicated for both exertional angina (by reducing myocardial oxygen demand) and vasospastic angina (by blocking coronary artery constriction).
$0.407MPart D
LOE ApproachingApproaching loss of exclusivity signals transition from brand-defense to cost-optimization roles; Customer Success and Demand Generation teams are currently active, indicating focus on managed market penetration.
Mechanism of Action
(calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac…
Indications
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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.