Twice a year, the FDA publishes an update of the List of Off‑Patent, Off‑Exclusivity Drugs without an Approved Generic (see the December 2024 listing here). This list is designed to generate interest from the industry in increasing competition among such products and it is made up of two parts. Part I is for drugs for which the path to approval is relatively clear cut while Part II is for products that may have a dodgy regulatory path to approval and for which the Agency suggests that potential sponsors have in‑depth discussions with the OGD prior to proceeding on development. Some of the products in Part II of the list may not qualify for ANDA submissions; they may be more suitable for 505(b)(2) NDA submissions, and it’s best to know that as early in development as possible.
There are two separate lists as well, one for prescription drug products and the other for over-the-counter (OTC) drugs. (Each of these lists is broken down into the two parts described above.) There is also an Appendix to each list that identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list’s publication.
This current list identifies 376 off-patent prescription drug products in Part I and 96 prescription drugs in Part II. The previous list published six months ago had 382 off-patent prescription drugs in Part I and 106 prescription drugs in Part II. The Appendix lists thirteen products that have been removed from the list because ANDAs have been approved since the list’s last publication.
As far as December’s OTC lists, Part I contains 26 individual products and Part II contains 29 products. The previous list contained 27 individual products in Part I and 29 in Part II. The Appendix includes only one product removed since the OTC list’s last update.
While there are a lot of products on the list of off-patent, off-exclusivity drugs for which ANDAs can be submitted and approved, based on the number of approvals for products from the list between the six-month update periods, the number of ANDAs that have been approved is relatively small!
