TheraRadar
Data updated: May 26, 2026

DOPTELET (avatrombopag maleate)

Priority Review
Hepatology Approved 2018-05-21

Doptelet treats low platelet counts in adults with chronic liver disease who are preparing to undergo a medical procedure. It also helps adults and children at least one year old with chronic or persistent immune thrombocytopenia (ITP) who have not seen enough improvement with previous therapies. This oral medication is used to raise and maintain platelet levels in these specific patient groups.

Source: FDA Label • AKARX INC

How DOPTELET Works

This medication works by targeting and stimulating thrombopoietin (TPO) receptors to trigger the growth and development of megakaryocytes in the bone marrow. This process results in the increased production of platelets. It does not compete with the body's natural TPO for receptor binding, allowing it to have an additive effect on platelet generation.

3
Indications
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2018-05-21
Patent Cliff
2027

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: AVATROMBOPAG MALEATE

DOPTELET Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2018 to 2025 · 2 indication expansions
Jul 2025 SUPPL
Efficacy
Jul 2024 SUPPL
Label · Labeling
Oct 2021 SUPPL
Label · Labeling

What DOPTELET Treats

3 indications

DOPTELET is approved for 3 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Thrombocytopenia
  • Chronic Liver Disease
  • Immune Thrombocytopenia
Source: FDA Label

DOPTELET Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in DOPTELET's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DOPTELET treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to DOPTELET

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DOPTELET SPRINKLE
AVATROMBOPAG MALEATE
3 shared
AKARX INC
Shared indications:
ThrombocytopeniaChronic Liver DiseaseImmune Thrombocytopenia
ALVAIZ
ELTROMBOPAG CHOLINE
2 shared
Teva
Shared indications:
ThrombocytopeniaImmune Thrombocytopenia
ELTROMBOPAG OLAMINE
ELTROMBOPAG OLAMINE
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Dr. Reddy's
Shared indications:
ThrombocytopeniaImmune Thrombocytopenia
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Active Pipeline

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Key Completed Trials

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Trial Timeline

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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.

DOPTELET FDA Label Details

Indications & Usage

FDA Label (PDF)

DOPTELET is indicated for the treatment of Thrombocytopenia; Chronic Liver Disease; Immune Thrombocytopenia.

View full patent landscape →
1 OB patents · 1 families · 39 international docs across 17 countries

DOPTELET Patents & Exclusivity

Latest Patent: Jul 2027
Exclusivity: Jul 2028

Patents (1 active)

US7638536 Expires Jul 28, 2027

Exclusivity

I-974 Until Jul 2028
ODE-246 Until Jun 2026
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2027
  • 1 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 10 similar drugs
  • Same target/indication analysis
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Data Sources

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