Janssen has discontinued all brand-name Duragesic® opioid analgesic (fentanyl transdermal system) patches

October 14, 2020 · Clinical Team

The U.S. Food and Drug Administration (FDA) reported that the brand-name opioid analgesic, Duragesic (fentanyl transdermal system), manufactured by Janssen Pharmaceuticals, Inc., is being discontinued. According to the FDA’s website, Janssen made a business decision to permanently discontinue all Duragesic transdermal systems and indicated they should be maintained on formularies until the last produced batch expires on July 31, 2021 to maintain continuity of the reimbursement process. No additional information was provided on Janssen’s website related to its business decision.

Impact on workers’ compensation and auto no-fault

We will not make any changes to our standard formularies at this time as brand-name Duragesic may still be dispensed if pharmacies have adequate quantities available to them. In addition, generic fentanyl transdermal systems may also be prescribed and would be permitted on any formulary where this medication is allowed.

From now until the product expiration on July 31, 2021, we would expect to see decreased use of the brand-name product. This will likely drive utilization of the lower cost generic products or alternative agents, which could reduce settlement and Medicare Set-Aside (MSA) costs.

General recommendations for use and availability

Fentanyl transdermal system, also referred to as a fentanyl patch, is a long-acting opioid analgesic indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment. It is important to mention the brand-name Duragesic is available in five different strengths, including 12 mcg/hour, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour. Currently, generic fentanyl transdermal systems are produced in these five strengths, and three additional strengths, by a number of generic manufacturers.

To access the FDA Drug Shortages website and company contact information, please click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:
1. U.S. Food and Drug Administration (FDA). FDA Drug Shortages. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Fentanyl (Duragesic 100, 12, 25, 37, 50, 75) Extended-Release Film. April 1, 2020. Available at: https://www.accessdata.fda.gov/DURAGESIC.
2. Duragesic (fentanyl transdermal system). Janssen Pharmaceuticals, Inc. Consumer Website. Last updated July 2020. Available at: https://www.duragesic.com/. Accessed October 13, 2020.