The purpose of this study was to estimate the cost of generic drug development and approval. This study develops an analytical framework for examining the expected net present value (ENPV) (i.e., the difference between the present value of expected revenues over product life and cost of product development and approval) to a generic drug developer in different size drug markets. The developed framework forms the basis for an accompanying operational model that enables the user to specify numerous details of a generic drug development project and provides cost, revenue, and ENPV estimates for the project being examined.
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