In speaking with prospective clients, 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. Some thoughts on a couple of categories:
Existing Products – What other drugs are available for the same therapeutic indication(s)? Why would the medical profession select yours?
Generic Drugs – Given that the RLD for 505(b)(2) drugs is off or coming off patent, the RLD will become generic. How will your drug compete with the low-priced generic?
Development pipeline – You need to look at drugs in the pipeline for your targeted therapeutic area (same indications). Information can be gleaned from posters/abstracts/presentations at medical society meetings and from Phase 2 & 3 clinical trial listings. This information can be helpful to design your clinical studies to assure that not only do you meet FDA requirements but that you obtain the information to compete against these pipeline drugs when they are approved.
“Same” product – Hopefully you’re looking over your shoulder, but if another company is developing the “same” drug product, and it gets approved first, it becomes the new RLD and you have to start your development over.