TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

XARACOLL

BUPIVACAINE HYDROCHLORIDE
Approved 2020-08-28
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-08-28
Routes
IMPLANTATION
Dosage Forms
IMPLANT

Companies

INNOCOLL PHARMS
Active Ingredient: BUPIVACAINE HYDROCHLORIDE

XARACOLL Approval History

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What XARACOLL Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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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.

XARACOLL FDA Label Details

Pro

XARACOLL Patents & Exclusivity

Latest Patent: Jan 2033

Patents (2 active)

US11746141 Expires Jan 9, 2033
USRE47826 Expires May 20, 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA209511 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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