Identifying Products For Drug Development Programs

Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff – few products coming off patent after 2016 – and is looking for alternative revenue sources. They know that the 505(b)(2) new drug application (NDA) pathway can be used to make changes to reference products, but a major question is which products offer the greatest profit potential and least risk.

For innovative pharmaceutical companies, opportunities for new products exist within the products, patents, technologies, and intellectual properties they already own or control. But for generic companies, there is usually no basis other than their manufacturing capabilities upon which to select a 505(b)(2) candidate.

Working with a contract research organization (CRO) with extensive 505(b)(2) experience can offer the right process to identify products that have documented market differentiation.

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