TMCnet - World's Largest Communications and Technology Community



Research and Markets: Dabigatran (Pradaxa): Generic Drug Opportunity Assessment Report - 3 Active Patents Due to Expire in 2018, 2025 & 2027
[January 24, 2014]

Research and Markets: Dabigatran (Pradaxa): Generic Drug Opportunity Assessment Report - 3 Active Patents Due to Expire in 2018, 2025 & 2027

DUBLIN --(Business Wire)--

Research and Markets ( has announced the addition of the "Generic Drug Opportunity Assessment - Dabigatran (Pradaxa)" report to their offering.

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).


  • Currently, there are no additional FDA-approved API suppliers of dabigatran listed in the Drug Master Files.


  • Three active patents covering Pradaxa are listed in the FDA Orange (News - Alert) Book. These patents expire in 2018, 2025, and 2027.

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

For more information visit

[ Back To's Homepage ]

Technology Marketing Corporation

35 Nutmeg Drive Suite 340, Trumbull, Connecticut 06611 USA
Ph: 800-243-6002, 203-852-6800
Fx: 203-866-3326

General comments:
Comments about this site:


© 2018 Technology Marketing Corporation. All rights reserved | Privacy Policy