Webinar: First-to-file and Beyond: A Look at Paragraph IV Business Strategies

Sponsored by: Thomson Reuters

Focused on:

    Date: 22rd March

    Days old: 4703

    Time: 3PM London / 11AM New York

    Balancing Risk and Reward in the Competitive Marketplace

    Anyone with even a casual interest in the US pharmaceutical market is aware the Paragraph IV patent challenge strategy is ubiquitous among top tier generic drug companies. Many smaller companies have also chosen to follow the Paragraph IV path, attempting to balance risk versus reward in a highly competitive marketplace.

    Some of the questions the webinar will address are:

    • How will the current competitive environment affect the strategies of large and small generic players?
    • How does the risk/reward calculation differ for smaller companies?
    • What are some of the potential pitfalls of the push to be first to file?
    • What is the value of being a subsequent filer?
    • Is a Paragraph IV strategy absolutely necessary for those seeking a share in the U.S. generic market?

    • An examination of some individual case studies will provide answers to these questions and insights that inform future generic strategies.

      Register Now

    Presented by

    Benjamin Burck,

    Research Analyst and Project Manager

    Benjamin Burck is responsible for the Paragraph IV patent challenge coverage that appears in Thomson Reuters Newport products. Ben joined Thomson Reuters in 2005 as an analyst on the Newport API intelligence team, gathering and validating competitive intelligence on the worldwide active ingredients market.

    Key Learning Objectives

    • Brief overview of the Paragraph IV patent challenge process.
    • Outline ANDA filing trends among large and small generic drug companies.
    • Identify possible rewards and risks of pursuing first-to-file status.
    • Highlight cost/benefit considerations behind Paragraph IV strategy.

    Audience

    • CEO/President/Chairman/Executive Director
    • C-Level Executives
    • Heads of Procurement
    • Generics and API Responsibilities
    • Heads of Portfolio Management
    • Heads of Business Development
    • Heads of Pharmaceuticals and/or Biotechnology
    • Project Managers
    • Heads of Strategic Planning
    • Heads of Marketing
    • Competitive Intelligence
    • Director/Head of Manufacturing