FENTANYL CITRATE generics — when can they launch?
FENTANYL CITRATE (FENTANYL CITRATE) · · 18 active US patents · 0 expired
Where FENTANYL CITRATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for FENTANYL CITRATE expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Formulation — 13 patents
- Method of Use — 5 patents
FDA U-codes carved out by FENTANYL CITRATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-767 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the FENTANYL CITRATE drug page →
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This patent protects methods and devices for delivering medicaments, such as fentanyl, through the mucous membranes for enhanced uptake.USPTO title: Transmucosal delivery devices with enhanced uptake
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This patent protects methods and devices for delivering medicaments, such as fentanyl, through the mucous membranes for enhanced uptake.USPTO title: Transmucosal delivery devices with enhanced uptake
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This patent protects methods and devices for delivering medicaments, such as fentanyl, through the mucous membranes for enhanced uptake.USPTO title: Transmucosal delivery devices with enhanced uptake
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This patent protects methods and devices for delivering medicaments, such as fentanyl, through the mucous membranes for enhanced uptake.USPTO title: Transmucosal delivery devices with enhanced uptake
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This patent protects methods and devices for delivering medicaments, such as fentanyl, through the mucous membranes for enhanced uptake.USPTO title: Transmucosal delivery devices with enhanced uptake
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This patent protects effervescent oral opiate dosage forms that contain substantially less opiates by weight than known oral formulations.USPTO title: Effervescent oral opiate dosage forms and methods of administering opiates
Sources
- FDA Orange Book — patents listed against FENTANYL CITRATE (NDA filed 1968)
- FENTANYL CITRATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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