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Generic Drug Opportunity Assessment : Dabigatran (Pradaxa)

  • January 2014
  • Greystone Research Associates
Report ID: 1973868

Summary

Greystone Research Associates has identified a branded drug that represents an attractive opportunity for generic drug companies. Details of our findings are contained in an insightful assessment.

Overview

Pradaxa (dabigatran etexilate) is a novel reversible oral direct thrombin inhibitor that blocks the activity of thrombin, the central enzyme in clot formation. It is approved for the primary prevention of venous thrombo-embolism (VTE) in adults who have undergone elective total hip or knee replacement surgery and was the first new anticoagulation therapy in half a century to be approved for the prevention of stroke and systemic embolism for adult patients with non-valvular atrial fibrillation who are at risk of stroke.

The Market
Atrial fibrillation (AF) increases the risk of stroke. The degree of increase can be substantial, depending on the presence of additional risk factors (such as high blood pressure). Atrial fibrillation may be treated with medications to either slow the heart rate to a normal range (rate control) or revert the heart rhythm to normal (rhythm control). The prevalence of AF in a population increases with age, with 8% of people over 80 having AF. Chronic AF leads to a small increase in the risk of death.
Nonvalvular atrial fibrillation is AF in the absence of rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair. Apixaban (Eliquis), is one of a group of novel oral anticoagulants (NOACs) that are more convenient, and are at least equally effective and safer (regarding bleeding complications) for stroke prevention compared with vitamin K antagonists (VKAs).

Report Highlights

Pradaxa – The Brand
Dabigatran – The Market
Dabigatran – The Opportunity
Manufacturing and Sourcing
Pradaxa Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario

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