Sold as Duragesic-100, Duragesic-75, Duragesic-50, Duragesic-25, Duragesic-12 and 2 more. Every FDA application for this active ingredient: 2 branded and 10 generic.
As of Nov 13, 2026, FDA lists 12 applications for Fentanyl (sold as Duragesic-100, Duragesic-75, Duragesic-50 and others), first approved Aug 7, 1990, with 3 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2024 | Change | Beneficiaries |
|---|---|---|---|---|
| Fentanyl | Part D | $92.4M | -6% | 116,822 |
| Fentanyl Citrate | Part D | $886K | -36% | 59 |
| Fentora | Part D | $661K | -43% | 0 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 7, 1990 | Duragesic-100, Duragesic-75NDA 19813 · TYPE 2/3 | Janssen Pharms | 51 | Discontinued |
| Jan 28, 2005 | Fentanyl-25, Fentanyl-50ANDA 76258 | Mylan Technologies | 28 | Marketed |
| Aug 4, 2006 | Fentanyl-25, Fentanyl-50ANDA 77051 | Lavipharm Labs | 2 | Discontinued |
| Aug 20, 2007 | Fentanyl-25, Fentanyl-50ANDA 76709 | Actavis Labs Ut Inc | 13 | Discontinued |
| Aug 20, 2007 | Fentanyl-25, Fentanyl-50ANDA 77062 | Mayne Pharma | 13 | Discontinued |
| Oct 20, 2008 | Fentanyl-25, Fentanyl-50ANDA 77449 | Difgen Pharms | 25 | Marketed |
| Oct 16, 2009 | Fentanyl-25, Fentanyl-50ANDA 77775 | Noven | 8 | Discontinued |
| Feb 9, 2011 | Fentanyl-25, Fentanyl-50ANDA 77154 | Specgx LLC | 23 | Marketed |
| Jan 4, 2012 | SubsysNDA 202788 · New dosage form | Btcp Pharma | 20 | Discontinued |
| Nov 4, 2016 | Fentanyl-12, Fentanyl-25ANDA 202097 | Kindeva | 10 | Marketed |
| Jan 24, 2023 | Fentanyl-12, Fentanyl-25ANDA 209655 | Zydus Pharms | 5 | Discontinued |
| — | FentanylANDA 202577 | Mylan Pharms Inc | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
