NDAORALTABLET2 Generics Approved
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
11
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 9h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVALIDE is a fixed-dose combination of irbesartan (an angiotensin II receptor antagonist) and hydrochlorothiazide (a thiazide diuretic) approved for hypertension treatment. It works by blocking angiotensin II receptors to relax blood vessels and increasing sodium excretion to reduce fluid volume. Patients with hypertension, particularly those requiring dual-agent therapy for adequate blood pressure control, are the primary users.
$0.001BPart D
LOE ApproachingDeclining
With LOE approaching and modest Part D spending of $1M on only 1,569 claims in 2023, the brand team is likely small and focused on maximizing remaining patent life through market defense rather than expansion.
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 (11)
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/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
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination
Started Jun 2008
832 enrolled
Hypertension
Irbesartan/Hydrochlorothiazide to Control Elevated Blood Pressure to Target in Moderate to Severe Hypertensive Patients
Started Apr 2008
503 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.