NDAORALTABLET2 Generics Approved
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
14
Data completeness
6/8 — Strong
AVALIDE (irbesartan and hydrochlorothiazide) by Sanofi is angiotensin 2 receptor antagonists [moa]. Approved for thiazide diuretic [epc]. First approved in 1997.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVALIDE is a fixed-dose combination of irbesartan (an angiotensin II receptor blocker) and hydrochlorothiazide (a thiazide diuretic) administered orally as a tablet. It is indicated for the treatment of hypertension in patients who require dual antihypertensive therapy. The combination works by blocking angiotensin II-mediated vasoconstriction while reducing fluid volume, providing complementary blood pressure reduction.
$0.001BPart D
LOE ApproachingDeclining
AVALIDE is in late-stage lifecycle with declining commercial activity; brand teams should focus on maximizing remaining patent-protected revenue and preparing transition strategies.
Mechanism of Action
Angiotensin 2 Receptor Antagonists
Pharmacologic Class:
Thiazide Diuretic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Evaluation of the Fixed-dose Combination of Irbesartan/Atorvastatin in Type 2 Diabetic Patients Diagnosed With Hyperlipidemia and Hypertension
Started Aug 2016
11 enrolled
Type 2 Diabetes Mellitus
Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy
Started May 2012
158 enrolled
Hypertension
Irbesartan and Amlodipine Combination in Controlling Blood Pressure
Started Jul 2009
270 enrolled
Hypertension
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
Started Jul 2009
406 enrolled
Hypertension
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy
Started Jul 2009
435 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.