Table of Contents
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.
Boceprevir is a direct acting antiviral drug against the hepatitis C (HCV) virus It is an inhibitor (protease inhibitor) of the HCV non-structural protein 3 (NS3) serine protease. Protease inhibitors are a class of antiviral drugs that are widely used to treat HIV/AIDS and hepatitis caused by hepatitis C virus. Protease inhibitors prevent viral replication by selectively binding to viral proteases (e.g. HIV-1 protease) and blocking proteolytic cleavage of protein precursors that are necessary for the production of infectious viral particles. Boceprevir (Victrelis) and the competing telaprevir (Incivek, Vertex Parmaceuticals) are indicated in combination with peginterferon plus ribavirin for genotype-1 HCV infection, the main HCV genotype worldwide.
Hepatitis C virus (HCV) is transmitted mainly by blood-to-blood contact, although it may be transmitted through unsafe sex. An estimated 3.9 million (1.8%) in the U.S. have been infected with HCV, of whom 2.7 million are chronically infected. Globally, an estimated 170 million persons are chronically infected with HCV and 3 to 4 million persons are newly infected each year.
Incivek (telaprevir) is supplied by Vertex Pharmaceuticals. Incivek is an orally-administered HCV protease inhibitor for adults with genotype 1 HCV infection that is prescribed in combination with pegylated-interferon, or peg-IFN, and ribavirin, or RBV. Incivek was approved by the FDA, in the second quarter of 2011 and by Health Canada in the third quarter of 2011.
Incivek (telaprevir) is supplied by Vertex Pharmaceuticals. Incivek is an orally-administered HCV protease inhibitor for adults with genotype 1 HCV infection that is prescribed in combination with pegylated-interferon, or peg-IFN, and ribavirin, or RBV. Incivek was approved by the FDA, in the second quarter of 2011 and by Health Canada in the third quarter of 2011. In the third quarter of 2011, Vertex marketing partners Janssen Pharmaceutica, N.V., Mitsubishi Tanabe Pharma obtained marketing approval for telaprevir from the European Commission and the Japanese Ministry of Health, Labor and Welfare, respectively. Janssen markets telaprevir under the brand name INCIVO in Europe and other countries in its territories, and Mitsubishi Tanabe markets telaprevir under the brand name Telavic in Japan.
ANDA P (IV) Certification Activity
The antivirals segment has been one of the more active in recent years in terms of ANDA P 4 filings. There have been thirteen P (IV) patent certifications filed against branded antiviral drugs in the past three years.
Competition among antivirals is quite high due to the number of alternative therapeutic drugs available and also because of the generally low level of specificity for any given drug in the treatment of a particular viral condition. As a result ANDA first-filers typically have a narrow window in which to work to produce the revenue numbers in their forecasts. In this environment, pre-launch planning and secondary sources of supply for critical materials can be critical to the success of the filing.
Generic Revenue Opportunity
We are predicting that the ANDA first-filer entering the market in will capture of the total global market for boceprevir drugs for the treatment of HCV in calendar year . The majority of sales will come during the 180-day exclusivity period, at a price approximately of the brand price.
Victrelis – The Brand
Boceprevir – The Product
Boceprevir – The Market
Boceprevir – The Opportunity
Manufacturing and Sourcing
Victrelis 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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