NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROCARDIA XL (nifedipine) by Pfizer is calcium channel antagonists [moa]. First approved in 1989.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Procardia XL is an extended-release oral tablet containing nifedipine, a dihydropyridine calcium channel blocker that works by inhibiting calcium influx into vascular smooth muscle cells. It is indicated for hypertension and high blood pressure variability, with off-label use in premature labor, postpartum hypertension, and altitude-related conditions. The drug reduces peripheral vascular resistance and blood pressure through its mechanism as a calcium channel antagonist.
$2MPart D
LOE ApproachingDeclining
As a mature, approaching LOE product with modest Medicare spending ($2M), Procardia XL teams are likely focused on defensive positioning and cost management rather than expansion.
Mechanism of Action
Calcium Channel Antagonists
Pharmacologic Class:
Dihydropyridine Calcium Channel Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
Started Dec 2017
0Hypertension
Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
Started Jul 2017
871 enrolled
Hypertension
Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor
Started Jan 2017
36 enrolled
Obstetric Labor, Premature
Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
Started Dec 2016
99 enrolled
Hypertension
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension
Started Oct 2015
700 enrolled
Hypertension
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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.