Epanova generics — when can they launch?
Epanova (OMEGA-3-CARBOXYLIC ACIDS) · AstraZeneca · 4 active US patents · 0 expired
Where Epanova sits in the generic timeline
Imminent generic cliff: earliest active US patent for Epanova 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.
- Method of Use — 2 patents
- Formulation — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Epanova 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-2447 | (no description) |
U-1511 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Epanova drug page →
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This patent protects a soft gelatin capsule containing omega-3 polyunsaturated fatty acids in free acid form, made with gelatin extracted using an acid pre-treatment process.USPTO title: Type A gelatin capsule containing PUFA in free acid form
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This patent protects DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form derived from fish oil.USPTO title: DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
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This patent protects DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form and methods for their use.USPTO title: DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
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This patent protects DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form and methods for their use.USPTO title: DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Sources
- FDA Orange Book — patents listed against Epanova (NDA filed 2014)
- Epanova drug profile — full patent estate, indications, clinical trials, pricing
- AstraZeneca 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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