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 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROCARDIA XL is an extended-release oral tablet formulation of nifedipine, a dihydropyridine calcium channel blocker approved in 1989. It works by antagonizing calcium channels to reduce vascular smooth muscle contraction, lowering blood pressure and reducing myocardial oxygen demand. It is indicated for hypertension and angina pectoris.
$0.002BPart D
LOE ApproachingMature product approaching loss of exclusivity with declining revenue signals contraction of brand team and shift toward generic optimization support.
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
REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial
Started Oct 2015
168 enrolled
HypertensionHigh Blood Pressure Variability
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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.