NDAORALTABLET
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
6/8 — Strong
EXFORGE HCT (amlodipine valsartan and hydrochlorothiazide) by Novartis is angiotensin 2 receptor antagonists [moa]. Approved for angiotensin 2 receptor blocker [epc]. First approved in 2009.
Drug data last refreshed 20h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXFORGE HCT is a fixed-dose oral combination tablet containing amlodipine (calcium channel blocker), valsartan (ARB), and hydrochlorothiazide (thiazide diuretic) approved in 2009. It treats hypertension by blocking angiotensin II receptors, reducing peripheral vascular resistance, and promoting sodium/water excretion. This triple-therapy approach addresses resistant hypertension in patients requiring multi-drug management.
$988KPart D
LOE ApproachingDeclining
Mature, declining portfolio asset with minimal team expansion; roles focused on lifecycle management and generic transition planning rather than growth initiatives.
Mechanism of Action
Angiotensin 2 Receptor Antagonists
Pharmacologic Class:
Angiotensin 2 Receptor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Started Jul 2007
257 enrolled
Hypertension
A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
Started Jul 2004
1,422 enrolled
Hypertension
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension
Started Jul 2004
125 enrolled
HypertensionLeft Ventricular Hypertrophy
Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
Started Oct 2003
11,506 enrolled
Hypertension
Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Started Apr 2003
332 enrolled
Albuminuria
Worked on EXFORGE HCT at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.