NDAORALSUSPENSION
Approved
Jul 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
KATERZIA (amlodipine) by R-Pharm US 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 2019.
Drug data last refreshed 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KATERZIA is an oral suspension formulation of amlodipine, a calcium channel antagonist approved in 2019 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 particularly effective in vasospastic angina by blocking coronary artery constriction.
$0.001BPart D
Peak12.6 years to LOEProduct is at peak lifecycle stage with minimal Part D penetration (1,800 claims in 2023), suggesting niche market positioning and smaller commercial team footprint.
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.