Vascepa generics — when can they launch?
Vascepa (ICOSAPENT ETHYL) · Amarin Pharms · 122 active US patents · 0 expired
Where Vascepa sits in the generic timeline
Imminent generic cliff: earliest active US patent for Vascepa 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.
- Method of Use — 120 patents
- Formulation — 2 patents
FDA U-codes carved out by Vascepa 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-2707 | (no description) |
U-2706 | (no description) |
U-1287 | (no description) |
U-2695 | (no description) |
U-4105 | (no description) |
U-2961 | (no description) |
U-3052 | (no description) |
U-3669 | (no description) |
U-2690 | (no description) |
U-3240 | (no description) |
U-3292 | (no description) |
U-1478 | (no description) |
U-2691 | (no description) |
U-2689 | (no description) |
U-2692 | (no description) |
U-2693 | (no description) |
U-3209 | (no description) |
U-2997 | (no description) |
U-2700 | (no description) |
U-2688 | (no description) |
Sample patent estate
Showing 6 of 122 active US patents. View full estate on the Vascepa drug page →
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This patent protects a composition for preventing cardiovascular events in patients with multiple risk factors, including those with high cholesterol.USPTO title: Composition for preventing the occurrence of cardiovascular event in multiple risk patient
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This patent protects a composition for preventing cardiovascular events in patients with multiple risk factors, including those with high cholesterol.USPTO title: Composition for preventing the occurrence of cardiovascular event in multiple risk patient
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This patent protects a composition and/or method for preventing cardiovascular events in patients who have had cardiovascular angioplasty or are being treated for hyperlipidemia.USPTO title: Composition and/or method for preventing onset and/or recurrence of cardiovascular events
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This patent protects a composition and/or method for preventing cardiovascular events in patients who have had cardiovascular angioplasty or are being treated for hyperlipidemia.USPTO title: Composition and/or method for preventing onset and/or recurrence of cardiovascular events
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This patent protects methods of treating and/or preventing cardiovascular-related disease by administering a pharmaceutical composition containing eicosapentaenoic acid or a derivative thereof.USPTO title: Methods of treating hypertriglyceridemia
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This patent protects methods of treating and/or preventing cardiovascular-related disease by administering a pharmaceutical composition containing eicosapentaenoic acid or a derivative thereof.USPTO title: Methods of treating hypertriglyceridemia
Sources
- FDA Orange Book — patents listed against Vascepa (NDA filed 2012)
- Vascepa drug profile — full patent estate, indications, clinical trials, pricing
- Amarin Pharms patent portfolio
- 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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