NDAORALPELLETSPriority Review
Approved
Jun 2021
Lifecycle
Post-LOE
Competitive Pressure
50/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRADAXA (dabigatran etexilate) is an oral direct thrombin inhibitor anticoagulant approved in 2021 as a pellet formulation. It is indicated for stroke prevention in atrial fibrillation, treatment of deep vein thrombosis and pulmonary embolism, and reduction of recurrent thromboembolism risk. The drug works by selectively inhibiting thrombin, a key coagulation enzyme.
$176MPart D
Post-LOEPost-LOEPost-LOE lifecycle with $176M in Part D spending indicates mature product requiring defensive positioning and efficiency-focused team operations.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
Started Sep 2024
60 enrolled
Healthy VolunteerDabigatranBioequivalence Study
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
5 enrolled
Venous Thromboembolism
Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant
Started Jul 2023
45 enrolled
CoughHealthy
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.