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 17 monographs associated with 16 drug products on the OPOE list that are in the United States Pharmacopeia-National Formulary (USP-NF). The following 14 monographs are currently official.

Monograph name OPOE List Drug Name NDA Abbreviated Indication(s)*
DESVENLAFAXINE DESVENLAFAXINE 204150 Major depressive disorder
DEXMEDETOMIDINE INJECTION DEXMEDETOMIDINE HYDROCHLORIDE

206628

21038

Short-term intravenous sedation
ENTECAVIR ORAL SOLUTION ENTECAVIR 21798 Chronic hepatitis B

ETOPOSIDE PHOSPHATE

ETOPOSIDE PHOSPHATE 20457 Testicular and lung cancer
ETOPOSIDE PHOSPHATE FOR INJECTION ETOPOSIDE PHOSPHATE 20457 Testicular and lung cancer
EVEROLIMUS EVEROLIMUS 21560 Organ transplantation
EXENATIDE INJECTION EXENATIDE SYNTHETIC 21773 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
OXICONAZOLE NITRATE OXICONAZOLE NITRATE 20209 Topical fungal infections (ringworm)
TERIPARATIDE INJECTION TERIPARATIDE 211939 Osteoporosis
TRANEXAMIC ACID INJECTION TRANEXAMIC ACID 212020 Promotes blood clotting
ZOLEDRONIC ACID ZOLEDRONIC ACID 204016 Adjunct to cancer therapy

The following three monographs will be official on August 1, 2022 (ATAZANAVIR SULFATE) and December 1, 2022 (ARGATROBAN INJECTION, FOSAMPRENAVIR CALCIUM).

Monograph name OPOE List Drug Name NDA Abbreviated Indication(s)*
ARGATROBAN INJECTION ARGATROBAN 209552 prevents some types of blood clotting
ATAZANAVIR SULFATE ATAZANAVIR SULFATE 206352 HIV-1
FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM 22116 HIV-1

* Please see Drugs@FDA for additional information. The indications listed on this page are provided for informational purposes and do not necessarily represent a complete and accurate list of all indications for each product.

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