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Valsartan, hydrochlorothiazide and amlodipine
Valsartan, hydrochlorothiazide, and amlodipine, marketed by Novartis, is a combination therapy currently available in the market. The key composition patent is set to expire in 2028, providing a clear timeline for potential generic competition. The primary risk is the loss of exclusivity post-patent expiry, which could significantly impact revenue.
At a glance
| Generic name | Valsartan, hydrochlorothiazide and amlodipine |
|---|---|
| Sponsor | Novartis |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control (NA)
- Integration of Hypertension Management in HIV Care in Uganda (NA)
- Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (PHASE3)
- Role of ARNi in Ventricular Remodeling in Hypertensive LVH (PHASE2)
- Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension (PHASE3)
- Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension (PHASE3)
- ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
- Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Valsartan, hydrochlorothiazide and amlodipine CI brief — competitive landscape report
- Valsartan, hydrochlorothiazide and amlodipine updates RSS · CI watch RSS
- Novartis portfolio CI