Boston, MA -- (SBWIRE) -- 12/27/2012 -- Indication expansion is one of the most successful developmental lifecycle management strategies. However, it is also one of the most costly, requiring long and expensive clinical trials to be conducted, and therefore carries higher risks.
- Analysis of success drivers and resistors of indication expansion as a lifecycle management strategy.
- Discussion of the factors that influence the order of launch of a product in different indications.
- Case study analysis of recent successful and unsuccessful indication expansion strategies.
Developing and patenting the use of a drug in an additional indication is an attractive lifecycle management strategy for pharma, not least because it can result in higher sales in the mid-stages of a drug's lifecycle, affording additional market exclusivity as well as patent protection and thus a longer lifecycle.
Companies may decide to launch the drug approved for a new primary indication as a separate brand. However, its positioning needs to be clear, especially in a large portfolio where multiple brands exist (brand, generic, over-the-counter).
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Getting the order of entry right is critical and companies developing indication extensions are faced with a choice between quickest approval or fastest uptake. Also, market exclusivity is triggered by launch in the first indication, thus shortening the time a product may be on the market for a larger patient population that may be approved later.
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- What are the advantages and disadvantages of launching a drug in additional indications early in the product lifecycle?
- How can off-label generics use undercut sales in additional indications and how can this be overcome?
- What factors influence the order of product launch in diifferent indications?
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