NDAORALTABLET
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
EXFORGE (amlodipine besylate and valsartan) by Novartis is angiotensin 2 receptor antagonists [moa]. Approved for angiotensin 2 receptor blocker [epc]. First approved in 2007.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EXFORGE is a fixed-dose combination of amlodipine besylate (calcium channel blocker) and valsartan (angiotensin II receptor blocker) approved in 2007 for hypertension management. It reduces blood pressure through dual mechanisms: vasodilation and renin-angiotensin system inhibition. This oral tablet is indicated for patients requiring dual antihypertensive therapy.
$2MPart D
LOE ApproachingDeclining
Mature product with declining claims volume and modest spending; commercial team likely focused on defending share against generics and sister products.
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 (3)
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Started Jul 2012
51 enrolled
Healthy Male Volunteer
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
Started May 2010
564 enrolled
Hypertension
A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
Started Dec 2005
160 enrolled
Chronic Heart Failure
Career Relevance
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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.