In speaking with sponsors, we often discuss the potential competition to their proposed drug product. In order to have success in the market, the proposed product needs market differentiation.

Existing products

What other drugs are available for the same therapeutic indication(s)? Why would the medical profession select yours?

Generic drugs

If you are developing a 505(b)(2) product, the associated reference listed drug (RLD) will become generic at some point (if it hasn’t already). How will your drug compete with the low-priced generic?

Development pipeline

You need to look at drugs in the pipeline with the same indication for your targeted therapeutic area. Information can be gleaned from posters, abstracts, and presentations at medical society meetings and from Phase 2 and 3 clinical trial listings. This information can be helpful to design your clinical studies to assure not only that you meet FDA requirements but also that you obtain the information to compete against these pipeline drugs when they are approved.

“Same” product

If another company is developing the “same” drug product that gets approved first, it becomes the new RLD, and your development program is set back significantly.