The FDA recently published an updated version of the Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (here). The list is broken down into two parts that identify either prescription or over‑the‑counter drugs (that require an ANDA as the subject of approval), and each of these respective lists is broken down into two sections: “Part I identifies those drug products for which the FDA could immediately accept an ANDA without prior discussion” and Part II “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.” (Part II is obviously more complex, for various reasons, than the Part I.)
In addition, there are appendices in the Rx and OTC sections that identify drug products removed from the previous list because an ANDA ha been approved for the products. Remember that in order for products to appear on these lists, there can be no unexpired periods of patent or exclusivity; thus, a product should be eligible for Competitive Generic Therapy designation, which might result in 180‑day exclusivity for the first approval and marketing of the product that receives designation.
The following table presents the targets available for ANDA submission in each category as well as the number of products removed from the previous list (in the appendix, as outlined above).
|Category||Part I||Part II||Appendix|
The FDA notes that, for some products in Part II of each list, it may be more appropriate to submit 505(b)(2) NDAs because of various complex scientific, regulatory, or legal issues that cannot be addressed with an ANDA filings. (That is why the FDA recommends discussion with the Agency prior to developing a submission strategy.)
This should give your development team something to think about (and maybe some heartburn)!