DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/496hfr/generic_drug) has announced the addition of the "Generic Drug Opportunity Assessment - Apixaban (Eliquis)" report to their offering.
Eliquis (apixaban) is an oral Factor Xa inhibitor - essentially an anticoagulant - targeting stroke prevention in atrial fibrillation and the prevention and treatment of venous thromboembolic (VTE) disorders. It is currently approved in the EU, Canada and Japan for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors and for use in VTE prevention in adult patients who have undergone elective hip or knee surgery. In December 2012, the U.S. Food and Drug Administration (FDA) approved Eliquis to reduce the risk of stroke and systemic embolism in patients with NVAF.
Patents & Exclusivity
The composition of matter patent covering apixaban in the U.S. expires in February 2023 (excluding potential patent term extensions) and in the EU it expires in 2022. The Company has applied for supplementary protection certificates. Some of these supplementary protection certificates have been granted and expire in 2026. Data exclusivity in the EU expires in 2021. The composition of matter patent expires in Canada in 2022. Eliquis has been granted exclusivity by the FDA under the exclusivity code NCE (New Chemical Entity). This exclusivity expires on December 24, 2017. The FDA is precluded by law to approve any ANDA prior this date.
Therapeutic Sector P (IV) Activity
Until recently, the cardiovascular drug sector has been quite active with regard to ANDA filings, with P (IV) certifications averaging about five per year since 2006 - 2010. This trend reflects the fragmented therapeutic environment. We expect the rate of P (iV) certifications to increase through 2018, as brand drugs lose exclusivity and patent protection.
In terms of the overall market growth for novel oral anticoagulants, Eliquis is expected to overtake Pradaxa as the overall market segment leader in 2016. We are also forecasting total global Eliquis revenue to exceed US $4 billion for the year 2017. The result will be a highly attractive generic market for the ANDA first-filer prepared to enter the market at the end of 2017 when the FDA exclusivity period for Eliquis is scheduled to expire.
- Eliquis - The Brand
- Apixaban - The Market
- Apixaban - The Opportunity
- Manufacturing and Sourcing
- Eliquis Patents and Exclusivity
- Therapeutic Class P4 Certifications
- Generic 1st-to-File Revenue Opportunity
- Business Risk Assessment
- First-to-File - Probabilistic Scenario
For more information visit http://www.researchandmarkets.com/research/496hfr/generic_drug
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