POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE (potassium phosphate, dibasic) · AMNEAL
Potassium Phosphates Injection is indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
Details
- Status
- Prescription
- First Approved
- 2019-11-26
- Patent Cliff
- 2041
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
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POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE Approval History
What POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE Treats
1 indicationsPOTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypophosphatemia
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE Competitive Set
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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AMNEAL's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Trial Timeline
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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.
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Potassium Phosphates Injection is indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacemen...
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE Patents & Exclusivity
Patents (2 active)
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Deep insights for POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE
Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2041
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.