Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). Intelence was the first medication in the class to demonstrate antiviral activity against NNRTI-resistant virus. Intelence (etravirine) in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced patients ages 6 years and older, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
The demand for ARVs is well established and it will continue to expand for many years: life expectancy has been dramatically extended; treatment is lifelong and is now being recommended regardless of a person’s CD4 T-cell count; rates of new infections and diagnoses remain high in many countries and in specific populations; and even optimistic reviewers see advances toward a cure as a long-term goal, at least a decade away.
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.
ABOUT THIS REPORT
This report is part of the Generic Drug Opportunity Reports series. These reports are designed to allow Industry managers to understand and evaluate the market potential for selected branded drugs from the viewpoint of creating and refining FDA ANDA regulatory filings in pursuit of first-filer generic drug applications. Each report contains timely and insightful data and information on drugs that have been approved by the FDA under existing New Drug Applications (NDA), and which have one or more Orange Book listed patents with patent expiration dates that fall in 2016 or beyond, providing interested market participants with a time window to prepare and submit an ANDA filing.
Each Generic Market Opportunity Assessment includes data and analysis on key strategic and tactical factors designed to provide generic drug managers with decision support tools in the form of specific and comprehensive information and data.
Intelence – The Brand
Etravirine – The Product
Etravirine – The Market
Etravirine – The Opportunity
Manufacturing and Sourcing
Intelence Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario