List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
To improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) for drugs with limited competition, FDA is publishing a list, consistent with the methodology described below, of approved new drug application (NDA) drug products that are off-patent and off-exclusivity, and for which the FDA has not approved an ANDA referencing that NDA drug product. Part I of the list 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. Sponsors wishing to pursue approval of AN...