Supporting patient access to quality medicines

U.S. Pharmacopeia (USP) is committed to support FDA’s List of Off-Patent, Off-Exclusivity Drug Products without an Approved Generic (OPOE) to expedite greater access for important generic drug therapies and help ensure quality and scientific rigor during drug development and manufacturing. We recognize that the pharmaceutical manufacturing industry, FDA, public health community (patient organizations and healthcare practitioners) and USP all share a collective priority to expand patient access to safe, quality medicines. Through initial discussions with these key stakeholders, USP has prioritized FDA’s OPOE list, and launched a Call for Collaboration to advance our shared priorities.

As an organization committed to patient access to quality medicines, we invite you to participate in the Call for Collaboration. The Call for Collaboration bridges the voice of the patient with the scientific and technical capabilities of FDA, USP and pharmaceutical manufacturers.

Successful implementation includes:

  • Active engagement and communication with the patient community and their advocates who identify gaps in access to critical therapies
  • Regular dialogue with USP’s scientific staff
  • Support for the pharmaceutical manufacturers efforts to develop new generic medicines from the OPOE list

USP has monitored the OPOE list to identify opportunities where public quality standards can help increase access to high impact public health medicines. We mapped our monograph development work, prioritized and identified areas where compendial standards can help increase access to quality medicines. We are engaging with stakeholders to help us prioritize more than 450 drugs on the OPOE list. Join the collaboration to advance shared priorities and explore how our monograph development efforts can facilitate greater patient access to quality medicines.

Since 2017, USP has developed 12 monographs associated with 11 drug products on the OPOE list that are in the United States Pharmacopeia-National Formulary (USP-NF). The following nine monographs are currently official.

Monograph name OPOE Drug Name NDA Indication
DESVENLAFAXINE DESVENLAFAXINE 204150 Treats depression
DEXMEDETOMIDINE INJECTION DEXMEDETOMIDINE HYDROCHLORIDE 206628 Sedation for surgery
ENTECAVIR ORAL SOLUTION ENTECAVIR 21798 Treats hepatitis B
EXENATIDE INJECTION EXENATIDE SYNTHETIC 21773 Treats type 2 diabetes
GADOTERATE MEGLUMINE INJECTION GADOTERATE MEGLUMINE 204781

MRI contrast agent (typically for brain and spine disorder diagnosis)

LINEZOLID LINEZOLID 206473 Anti-bacterial
MESNA TABLETS MESNA 20855 Reduces risk of serious side effects from cancer chemotherapy (reduces risk of bleeding in the bladder from) bladder inflammation
TERIPARATIDE INJECTION TERIPARATIDE 211939 Treats osteoporosis
TRANEXAMIC ACID INJECTION TRANEXAMIC ACID 212020 Promotes blood clotting

The following three monographs will be official on December 1, 2021.

Monograph name OPOE Drug Name NDA Indication
ETOPOSIDE PHOSPHATE; 
ETOPOSIDE PHOSPHATE FOR INJECTION
ETOPOSIDE PHOSPHATE 20457 Treats certain lung and testicular cancers
ZOLEDRONIC ACID ZOLEDRONIC ACID 204016 Treats myeloma and other cancers

USP is continuing to prioritize monographs associated with drug products on the OPOE list to help support the development of new generic drug products to foster a more competitive marketplace for medicines.

Join the Call

The Call for Collaboration brings together USP, FDA, the patient advocacy community and pharmaceutical manufacturers who are committed to create quality generic medicines for legacy drugs without alternatives. Join us in this collective public health effort to increase access to quality medicines for patients who need them.

For more information: CallforCollaboration@usp.org