First issued in June of 2017, the FDA has updated the List of Drug Products Without Competition (here). The “List” also includes an Appendix that removes 11 products because approvals of a generic have occurred since the initial publication of the List.
We first reported on the “List” here, and it has taken only two (2) years for 11 products to have been approved under the expedited program. Unfortunately, there is no way to know how many products on the List have ANDAs pending at the Agency, however, there still appears to be a lot of targets for ANDA applicants to go after. The question is, what products will be deemed to have a profit-margin that would make the products attractive as real opportunities? I expect we will see a number of more approvals over the next year or so, but many products have likely fallen out-of-favor, or used more because of new or improved product introductions.
There still may be a niche for some smaller companies for many of these products. We will have to wait and see if the approvals begin to flow, or if the List does not represent the type of opportunity for which the Agency had hoped. The List is updated every six (6) months, so it will be interesting to watch the new Appendix (that identifies products removed from the List because ANDA or 505(b)(2) products have been approved) grow.