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 19 monographs associated with 18 drug products on the OPOE list that are in the United States Pharmacopeia-National Formulary (USP-NF). The following 19 monographs are currently official.
| USP Monograph name | OPOE List Ingredient Name | Approved NDA | Abbreviated Indication(s)* |
| ARGATROBAN INJECTION | ARGATROBAN | 209552 | Prevents some types of blood clotting |
| ARTEMETHER | ARTEMETHER; LUMEFANTRINE | 022268 | Antimalarial |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | 206352 | HIV-1 |
| DESVENLAFAXINE | DESVENLAFAXINE | 204150 | Major depressive disorder |
| DEXMEDETOMIDINE INJECTION | DEXMEDETOMIDINE HYDROCHLORIDE |
206628 21038 |
Short-term intravenous sedation |
| EMTRICITABINE | EMTRICITABINE | 021896 | HIV-1 |
| 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 |
| FOSAMPRENAVIR CALCIUM | FOSAMPRENAVIR CALCIUM | 22116 |
HIV-1 |
| 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 monographs are currently under development by USP and have been proposed for comment in Pharmacopeial Forum.
| Monograph name | OPOE List Ingredient Name | Approved NDA | Published |
|
DOXAZOSIN MESYLATE EXTENDED-RELEASE TABLETS |
DOXAZOSIN MESYLATE | N021269 | Emerging Standards (usp.org) (posted November 2023) |
|
DOXEPIN HYDROCHLORIDE CREAM |
DOXEPIN HYDROCHLORIDE | N020126 | Emerging Standards (usp.org) (posted November 2023) |
|
NEOSTIGMINE METHYLSULFATE |
NEOSTIGMINE METHYLSULFATE INJECTION | N203629 | PF 49(6) Link to proposal |
|
NEOSTIGMINE METHYLSULFATE INJECTION |
NEOSTIGMINE METHYLSULFATE INJECTION | N203629 | PF 49(6) Link to proposal |
|
BEXAROTENE |
BEXAROTENE GEL | N021056 | PF 49 (5) Link to proposal |
|
ARTEMETHER AND |
ARTEMETHER; LUMEFANTRINE |
N022268 | PF 47(5) Link to proposal |
|
SODIUM NITROPRUSSIDE INJECTION |
SODIUM NITROPRUSSIDE | N209387 | PF 48(6) Link to proposal |
|
TRIPTORELINE PAMOATE |
TRIPTORELINE PAMOATE | N020715 | PF 48(5) Link to proposal |
| AZELAIC ACID | AZELAIC ACID | N020428 | PF 49(3) Link to proposal |
| TAZAROTENE | TAZAROTENE |
N020600 |
PF 48(5) Link to proposal |
| BIVALIRUDIN | BIVALIRUDIN | N208374 | PF 48(2) Link to proposal |
| CLOBETASOL PROPIONATE LOTION | CLOBETASOL | N213691 | PF 47(2) Link to proposal |
| OXICONAZOLE NITRATE LOTION | OXICONAZOLE | N020209 | PF 43(2) Link to proposal |
* 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