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

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







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

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.

On March 23, 2020, FDA removed the listings for biological products that had been approved in applications under section 505 of the FD&C Act from Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) because these products are no longer “listed drugs.”  The June 2020 update to the Off-Patent, Off-Exclusivity List is the first update after this transition, so we have removed any biological products that had previously been included on the list. 

FDA maintains this list to improve transparency and encourage the development and submission of applications under an abbreviated approval pathway for drugs with limited competition. We update this list every six months to ensure continued transparency regarding drug products where increased competition has the potential to provide significant benefit to patients. For more information on our efforts to bring more drug competition to the market and address the high cost of medicines, visit the Drug Competition Action Plan (DCAP) web page.

We are pleased to share that, in support of DCAP and the U.S. Pharmacopeia (USP) Generics Access Plan, USP has prioritized FDA’s list of off-patent, off-exclusivity branded drugs without approved generics, and launched a Call for Collaboration to advance our shared priorities. USP has identified opportunities where public quality standards can help increase access to medicines with great potential benefit to the public health.