On June 13th, the 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 FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA.
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. 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. This list is also useful within FDA as we develop additional product-specific guidances and other resources to assist prospective ANDA applicants. 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.
Call for Collaboration with U.S. Pharmacopeia (USP)
In support of DCAP and the USP Generics Access Plan, USP has prioritized the development of monographs associated with drug products on the OPOE list, identifying opportunities where public quality standards can help increase access to medicines with great potential benefit to the public health. To date, USP has developed 19 monographs, associated with 18 drug products on the OPOE list, including treatments for HIV and some cancers. These monographs are currently official in the USP-NF.
USP recently announced a Call for Collaboration to help prioritize more than 550 drugs on the OPOE list. Join the collaboration to advance our shared priorities and explore how monograph development efforts can facilitate greater patient access to quality medicines.
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