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Pradaxa

(Dabigatran Etexilate Mesylate)

ApprovedSmall molecule

Boehringer Ingelheim

Pradaxa is one of 9 small molecule programs targeting Thromboembolism. It is currently in Approved.

1

Indications

6

Total Trials

0

Active Trials

8

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

4

Patents

Pipeline

Status by Indication[3][1]

Indication

ThromboembolismCompleted

ThromboembolismApproved

Completed

Competition

Competitive Landscape

9 competitors in Thromboembolism

#DrugCompanyPhaseTrials

Eliquis

Bristol-Myers Squibb

Heparin Sodium

BBaxter Healthcare Corporation

Arixtra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Coumadin

Xylocaine

MMEDRx USA, Inc.

Pradaxa

Boehringer Ingelheim

Coumadin

Tissue Plasminogen Activator

NNeuroscience Trials Australia

Xarelto

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Clinical Trial1 trial

Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

Unknown status·HHuons Co., Ltd.·Phase 1·NCT03495739·64 enrolled

Interaction1 trial

A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02945020·15 enrolled

Thromboembolism1 trial

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

Completed·VVanderbilt University Medical Center·Phase 4·NCT01976507·101 enrolled

Tics1 trial

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04459585·20 enrolled

Acute Pancreatitis1 trial

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Terminated·MMayo Clinic·Phase 1·NCT03807856·2 enrolled

1 more indication

Unspecified1 trial

Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects

Completed·TThe Affiliated Hospital Of Guizhou Medical University·Phase 1·NCT06876623·88 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 19, 2010

PRADAXA

NDA NDA022512

Jun 21, 2021

PRADAXA

NDA NDA214358

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Dabigatran Etexilate Mesylate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dabigatran Etexilate Mesylate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dabigatran Etexilate Mesylate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214358). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Pradaxa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Patent Landscape[5]

Patent Cliff

Jan 20, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7932273Sep 7, 2025

7932273*PEDMar 7, 2026

9034822Jan 20, 2031

9034822*PEDJul 20, 2031

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