BRIEF—FDA updates list of off-patent drugs without an approved generic

Today, the US Food and Drug Administration published an update to the “ List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” (OPOE list).

The OPOE list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of each update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA.

The FDA maintains the OPOE list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition.

This list is also useful within FDA, the agency notes, as it develops additional product-specific guidances and other resources to assist prospective ANDA applicants.