[January 24, 2014] |
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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 (http://www.researchandmarkets.com/research/jzd4jf/generic_drug)
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).
API
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Currently, there are no additional FDA-approved API suppliers of
dabigatran listed in the Drug Master Files.
Patents
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Three active patents covering Pradaxa are listed in the FDA Orange (News - Alert)
Book. These patents expire in 2018, 2025, and 2027.
Report Highlights
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Pradaxa - The Brand
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Dabigatran - The Market
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Dabigatran - The Opportunity
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Manufacturing and Sourcing
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Pradaxa Patents and Exclusivity
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Therapeutic Class P4 Certifications
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Generic First-to-File Revenue
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Opportunity
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Business Risk Assessment
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First-to-File - Probabilistic Scenario
For more information visit http://www.researchandmarkets.com/research/jzd4jf/generic_drug
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