PRADAXA

Peak

dabigatran etexilate mesylate

NDAORALCAPSULEPriority Review
Approved
Oct 2010
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17

Mechanism of Action

competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are…

Clinical Trials (5)

NCT05966740N/ATerminated

A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot

Started Apr 2024
6 enrolled
Venous Thromboembolism
NCT03495739Phase 1Unknown

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

Started Feb 2018
64 enrolled
Healthy
NCT03175198N/ACompleted

Japanese Pradaxa PMS, Long Term

Started Jul 2017
5,660 enrolled
Atrial Fibrillation
NCT03143166Phase 1Completed

Pradaxa Tablet Proton Pump Inhibitor (PPI) Bioavailability (BA) Study in Japan

Started May 2017
36 enrolled
Non-alcoholic Fatty Liver Disease
NCT02945020Phase 1Completed

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

Started Nov 2016
15 enrolled
Healthy

Loss of Exclusivity

LOE Date
Jul 20, 2031
65 months away
Patent Expiry
Jul 20, 2031

Patent Records (4)

Patent #ExpiryTypeUse Code
7932273
Sep 7, 2025Expired
SubstanceProduct
7932273*PED
Mar 7, 2026
9034822
Jan 20, 2031
U-1759
9034822*PED
Jul 20, 2031