TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

CUBICIN

DAPTOMYCIN
Approved 2003-09-12
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
4
Priority Reviews
22
Years on Market

Details

Status
Discontinued
First Approved
2003-09-12
Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

CUBIST PHARMS LLC
Active Ingredient: DAPTOMYCIN

CUBICIN Approval History

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What CUBICIN Treats

5 FDA approvals

Originally approved for its first indication in 2003 . Covers 5 distinct patient populations.

  • Other (5)
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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.

CUBICIN FDA Label Details

Pro

CUBICIN Patents & Exclusivity

Latest Patent: Nov 2030

Patents (4 active)

US9138456 Expires Nov 23, 2030
US8003673 Expires Sep 4, 2028
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA021572 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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