Epipen generics — when can they launch?
Epipen (epinephrine) · Pfizer Inc. · 70 active US patents · 1 expired
Where Epipen sits in the generic timeline
Imminent generic cliff: earliest active US patent for Epipen expires in 2026 (~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 — 43 patents
- Method of Use — 27 patents
FDA U-codes carved out by Epipen 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-1829 | (no description) |
U-3379 | (no description) |
U-2980 | (no description) |
U-3979 | (no description) |
U-3567 | (no description) |
Sample patent estate
Showing 6 of 70 active US patents. View full estate on the Epipen drug page →
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This patent protects a method for a medical injector's actuation lock mechanism, allowing it to move from a first position to a second position.USPTO title: Devices, systems and methods for medicament delivery
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This patent protects a method for a medical injector's actuation lock mechanism, allowing it to move from a first position to a second position.USPTO title: Devices, systems and methods for medicament delivery
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This patent protects a method for a medical injector's actuation lock mechanism, allowing it to move from a first position to a second position.USPTO title: Devices, systems and methods for medicament delivery
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This patent protects an apparatus with a label that can be attached to a medicament delivery device, such as an EpiPen.USPTO title: Devices, systems and methods for medicament delivery
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This patent protects an apparatus with a label that can be attached to a medicament delivery device, such as an EpiPen.USPTO title: Devices, systems and methods for medicament delivery
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This patent protects an apparatus with a label that can be attached to a medicament delivery device, such as an EpiPen.USPTO title: Devices, systems and methods for medicament delivery
Sources
- FDA Orange Book — patents listed against Epipen (NDA filed 1948)
- Epipen drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. patent portfolio
- Patent cliff 2026 — 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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