TheraRadar
Data updated: Mar 29, 2026

OCALIVA

OBETICHOLIC ACID
Approved 2016-05-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market

Details

Status
Discontinued
First Approved
2016-05-27
Routes
ORAL
Dosage Forms
TABLET

Companies

INTERCEPT PHARMS INC
Active Ingredient: OBETICHOLIC ACID

OCALIVA Approval History

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What OCALIVA Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • 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.

OCALIVA FDA Label Details

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OCALIVA Patents & Exclusivity

Latest Patent: Apr 2036

Patents (28 active)

US10758549 Expires Apr 26, 2036
US10751349 Expires Apr 26, 2036
US10052337 Expires Apr 26, 2036
US10047117 Expires Sep 6, 2033
US10174073 Expires Jun 17, 2033
US9238673 Expires Jun 17, 2033
USRE48286 Expires Feb 21, 2027
+ 18 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA207999 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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