TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PROMACTA

ELTROMBOPAG OLAMINE
Approved 2008-11-20
Jump to: Indications Approvals Trials Competitors Safety Patents
6
Indications
--
Phase 3 Trials
5
Priority Reviews
17
Years on Market

Details

Status
Discontinued
First Approved
2008-11-20
Routes
ORAL
Dosage Forms
TABLET

Companies

Novartis
Active Ingredient: ELTROMBOPAG OLAMINE

PROMACTA Approval History

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What PROMACTA Treats

6 FDA approvals

Originally approved for its first indication in 2008 . Covers 6 distinct patient populations.

  • Other (6)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

PROMACTA FDA Label Details

Pro

PROMACTA Patents & Exclusivity

Latest Patent: Jan 2028

Patents (395 active)

US8828430*PED Expires Feb 1, 2028
US8052993*PED Expires Feb 1, 2028
US8052994*PED Expires Feb 1, 2028
US8062665*PED Expires Feb 1, 2028
US8071129*PED Expires Feb 1, 2028
US8052994 Expires Aug 1, 2027
US8071129 Expires Aug 1, 2027
US8052993 Expires Aug 1, 2027
US8062665 Expires Aug 1, 2027
US8828430 Expires Aug 1, 2027
+ 385 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA022291 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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