Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Current List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

Find here and keep yourself updated on a list maintained by FDA of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product.

The list is updated by FDA every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition.

The list is separated into three sections:

  • Part I identifies those drug products for which FDA could immediately accept an ANDA without prior discussion.
  • 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.
  • The Appendix 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 publication.

Source: USFDA Website