Pradaxa

(Dabigatran Etexilate Mesylate)

ApprovedSmall molecule

Boehringer Ingelheim

Pradaxa is one of 56 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute PancreatitisActive, not recruiting

ThromboembolismActive, not recruiting

Acute PancreatitisPhase 1

Active, not recruiting

ThromboembolismApproved

Active, not recruiting

Competition

Competitive Landscape

69 competitors in Acute Pancreatitis

#DrugCompanyPhaseTrials

Relistor

Advil

Octreotide

1 4

Indocin

LLife Extension Foundation Inc.

Phase 3

3 5

Trental

VValidus Pharmaceuticals

Phase 3

2 6

Pradaxa

Boehringer Ingelheim

Approved

1 7

Ursodeoxycholic Acid

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 8

Symproic

BBioDelivery Sciences International

Phase 3

1 9

Activated Protein C

UUniversity of Roma La Sapienza

Approved

1 10

Toradol

JJavelin Pharmaceuticals

Phase 2

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

Clinical

Trials by Indication[1]

Acute Pancreatitis1 trial

Treating Acute Pancreatitis With Dabigatran, a Pilot Study

Terminated·MMayo Clinic·Phase 1·NCT03807856·2 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

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

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

Thromboembolism1 trial

Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism

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

Pradaxa

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Acute Pancreatitis1 trial

Interaction1 trial

Tics1 trial

Clinical Trial1 trial

Thromboembolism1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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