Off-Patent Drugs with No Competition Lists Updated

Today, the FDA published an update to the list of non-patented drug products and products that are protected by exclusivity provisions.  The new twist in the current version of the list is that it is in two parts.  One part covers prescription drug products and the other covers OTC products that are FDA-approved.  The list does not cover OTC monograph products.

Both lists still contain two parts, one with products for which there are no specific scientific issues such that firms should be able to submit applications directly without Agency input, and a second part with “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 number of products on each list is summarized in the table below:

The website also provides previous lists that the Agency has generated.  Comparison of the lists could then be used to determine which products have had a generic product approved since the last lists were published.  The new lists are updated twice per year.  All of this information is available on the FDA website here.