JAVADIN (clonidine hydrochloride) · AZURITY
Javadin helps adult patients with high blood pressure by lowering their readings to safer levels. Reducing blood pressure with this medication helps decrease the risk of cardiovascular events, such as strokes and heart attacks. It is often used as part of a comprehensive management plan that includes lifestyle changes and other medications to reach specific cardiovascular goals.
Details
- Status
- Prescription
- First Approved
- 2025-10-23
- Patent Cliff
- 2042
- Routes
- ORAL
- Dosage Forms
- SOLUTION
JAVADIN Approval History
What JAVADIN Treats
3 indicationsJAVADIN is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
JAVADIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in JAVADIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications JAVADIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to JAVADIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01439126 results posted | SHN-KAP-401 | Ph 4 | completed | Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JAVADIN FDA Label Details
Indications & Usage
FDA Label (PDF)JAVADIN is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with JAVADIN. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic...
JAVADIN Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for JAVADIN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.