TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

HECTOROL

DOXERCALCIFEROL
Approved 1999-06-09
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
26
Years on Market

Details

Status
Discontinued
First Approved
1999-06-09
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, CAPSULE

Companies

Sanofi
Active Ingredient: DOXERCALCIFEROL

HECTOROL Approval History

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What HECTOROL Treats

4 FDA approvals

Originally approved for its first indication in 1999 . Covers 4 distinct patient populations.

  • Other (4)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

HECTOROL FDA Label Details

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HECTOROL Patents & Exclusivity

Exclusivity: Jun 2028

Exclusivity

M-14 Until Jun 2028
M-14 Until Jun 2028
M-14 Until Jun 2028
M-14 Until Jun 2028
M-14 Until Jun 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA021027 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.