The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved. The revised list contains a 2-part listing and an appendix.
Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA without prior discussion”. In other words, these products are not complex and have a clear approval path. Part 2 contains 136 entries and “identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA.”
The FDA has also included an Appendix A that identifies drug products that have been removed from the list because 1 or more ANDA have been approved for products previously on Part 1 or Part 2. This list has 9 entries. The complete listing can be found here.
The fact that only 9 products have been removed from the lists may signify that it is either harder to gain approval for some of the products, or that there is little if any commercial value to these previously approved new drug products. FDA also mentions that it has not included NDA approved within the last year because there is not sufficient time for generics to be approved, and thus, it would make the list a bit disingenuous.
