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

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

Today, the U.S. Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. Both PDF and Excel formats are available for the current update and all previous updates.

The agency maintains this list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. The agency updates this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients.