With ANDA approval, one would expect that market entry would soon follow application approval, right? Wrong! The data suggests that only about 40% of generic drugs approved in any year are actually launched in that year and, after 5 years, there are still about 30% of those products that have still not launched. While this is a story in itself, the FDA’s issuance of a final guidance titled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format (here) outlines an important requirement for that subset of drugs that are approved but not marketed within the first 180 days post-approval.
While the guidance also covers notice requirements for discontinuations of drug products and products that are withdrawn, do not miss the need for providing notice to the Agency for new products that don’t come to market quickly. As the percentages outlined above suggest, if FDA approves 1000 ANDAs in any given year, then up to 400 of those are unlikely to launch that year and may be subject to the notification requirements of 506l of the Act. That is a lot of entries to be made through FDA’s gateway!
Once you have notified the FDA that your product will not be launched within the 180 days, FDA will move the product to the discontinued section of the Orange Book. If you decide to launch the product after the 180 days have passed, you then need to provide the FDA notice of the date you plan to begin marketing the product. Reasons for not launching within 180 days post approval may include any one of several things such as validation of manufacturing processes, availability of raw materials, changes in the market dynamics, or other more profitable products competing for manufacturing time.
The guidance asks that firms alert the FDA about initial introduction of the product that has not been launched within the 180 days and suggests that notification be sent to the Agency 30-60 days before planned product introduction, so that they have time to place the product back into the active section of the Orange Book. Beware, this 2-month period may impact reimbursement in the cases where you plan to initially market on something like day 200 or 240 after approval and there may not be time for FDA to make the Orange Book change. It is suggested that in such situations you have a discussion with the appropriate Office of Generic Drug Project Manager to obtain their view on the notification action in that short window and to see whether an exception can be made, if you have a date certain for introduction within a month or two after 180 days after approval.