List of Drug Products Without Competition – Constantly Changing!

The last post we did on this list was back in June 2020 (here ) and there were 269 products on Part I (those that firms can immediately submit an ANDA) and 136 on Part II (those products that may be more difficult and present various regulatory or scientific issues and for which FDA recommends contact and discussions with them prior to submission).  The numbers have been revised somewhat since that list published last year, with some being added and some being removed..

The updated list that published yesterday contains 312 products on Part I and 133 products on Part II.  An increase is expected as some firms drop out, or as patents and exclusivity expire on originator products for which there is still no generic competition.  The decrease in the Part II list was likely due to the approval of three (3) of the more challenging and difficult Part II products.

There is also an Appendix that contains a list of products approved since the last list (which was published in January 2021) and shows that seven (7) products were now approved and thus removed from the lists.

The ebb and flow of this list will likely continue over time, but the fact is that many of these products (even on Part I) present unique challenges that could impact approval, or the fact that newer approved NDA products that are either more efficacious or have a more robust safety profile had usurped the market and are favored over the older generation of products approved for similar indications.

The entire list can be found here and provides further explanations of the issues involved (this is also explained at greater length in the previous blog post at the link in the first paragraph).  It should also be noted that whether firms will be inspired to submit ANDAs for these products in the future depends on their evaluation of market opportunities and potential profit margin, given some of potential regulatory hurdles and scientific challenges and requirements and whether the firm is willing to invest in older products to compete with a potential newer product.