FDA updates list of off-patent, without an approved generic

The US Food and Drug Administration (FDA) 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 says it 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. It 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. This list is also useful within the FDA as it develops additional product-specific guidances and other resources to assist prospective ANDA applicants.