EZALLOR SPRINKLE (rosuvastatin calcium) · Sun Pharma
EZALLOR SPRINKLE is FDA-approved to treat 6 conditions (same as ROSUVASTATIN CALCIUM).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 2018-12-18
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- CAPSULE
EZALLOR SPRINKLE Approval History
What EZALLOR SPRINKLE Treats
6 indicationsEZALLOR SPRINKLE is approved for 6 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperlipidemia
- Atherosclerosis
- Heterozygous Familial Hypercholesterolemia
- Homozygous Familial Hypercholesterolemia
- Primary Dysbetalipoproteinemia
- Hypertriglyceridemia
Same approved indications as ROSUVASTATIN CALCIUM (same active ingredient).
Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03113994 RoBaCO | 2016-350642 | Ph 2 | terminated | Statin Monotherapy for Treatment of Endocrine Metabolic Disease Risk |
| NCT04319627 SAVER | SAVER Trial | Ph 3 | recruiting | Statins for Venous Event Reduction in Patients With Venous Thromboembolism |
| NCT04602754 | EMS1019 - Berlim 25/20 | Ph 3 | recruiting | Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia. |
| NCT06081166 | TA-8995-11 | Ph 1 | completed | A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin |
| NCT05828303 | CA127-1027 | Ph 1 | withdrawn | A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors |
| NCT01078675 results posted | D3561C00002 | Ph 3 | completed | An Study to Evaluate Rosuvastatin in Children and Adolescents With Familial Hypercholesterolaemia |
| NCT00766025 | D3560C00059 Rosuvastatin Calcium | Ph 1 | completed | Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin |
| NCT04621669 | SHR3680-I-DDI-03 | Ph 1 | completed | Drug-durg Interaction of SHR3680 With Digoxin, Rosuvastatin Calcium and Metformin Hydrochloride |
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.
EZALLOR SPRINKLE FDA Label Details
Indications & Usage
FDA Label (PDF)EZALLOR SPRINKLE is FDA-approved to treat 6 conditions — same approved indications as ROSUVASTATIN CALCIUM.
EZALLOR SPRINKLE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for EZALLOR SPRINKLE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 16 active patents
Trial Analysis
- • 9 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment