PRADAXA

Post-LOE

dabigatran etexilate

NDAORALPELLETSPriority Review
Approved
Jun 2021
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20

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)

NCT06693518Phase 1Completed

A Study to Learn About if the Study Medicine Called Ibuzatrelvir Changes How the Body Process the Other Medicine Dabigatran Etexilate in Healthy Adults

Started Nov 2024
20 enrolled
SARS-CoV-2 Infections
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
NCT05959447Phase 1Completed

Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant

Started Jul 2023
45 enrolled
CoughHealthy
NCT05673889Phase 1Completed

A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults

Started Jan 2023
24 enrolled
Healthy
NCT05438303Phase 1Completed

Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

Started Jun 2022
59 enrolled
Healthy Volunteers

Loss of Exclusivity

LOE Date
Mar 7, 2026
0 months away
Patent Expiry
Mar 7, 2026

Patent Records (2)

Patent #ExpiryTypeUse Code
7932273
Sep 7, 2025Expired
SubstanceProduct
7932273*PED
Mar 7, 2026