Nexletol generics — when can they launch?
Nexletol (BEMPEDOIC ACID) · Esperion Theraps Inc · 15 active US patents · 0 expired
Where Nexletol sits in the generic timeline
Mid-term cliff: earliest active US patent for Nexletol expires in 2030 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 7 patents
- Composition of Matter — 6 patents
- Formulation — 2 patents
FDA U-codes carved out by Nexletol 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-3883 | (no description) |
U-3884 | (no description) |
U-3873 | (no description) |
U-4258 | (no description) |
Sample patent estate
Showing 6 of 15 active US patents. View full estate on the Nexletol drug page →
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This patent protects novel hydroxyl compounds and compositions for treating and preventing various diseases and conditions, including cardiovascular disease and dyslipidemia.USPTO title: Hydroxyl compounds and compositions for cholesterol management and related uses
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This patent protects novel hydroxyl compounds and compositions for treating and preventing various diseases and conditions, including cardiovascular disease and dyslipidemia.USPTO title: Hydroxyl compounds and compositions for cholesterol management and related uses
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This patent protects compositions and methods for using fixed doses of ETC-1002 and ezetimibe to treat or reduce the risk of cardiovascular disease.USPTO title: Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
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This patent protects compositions and methods for using fixed doses of ETC-1002 and ezetimibe to treat or reduce the risk of cardiovascular disease.USPTO title: Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
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This patent protects compositions and methods for using fixed doses of ETC-1002 and ezetimibe to treat or reduce the risk of cardiovascular disease.USPTO title: Fixed dose combinations and formulations comprising ETC1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
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This patent protects methods of making bempedoic acid and compositions containing it, as well as methods of treating various diseases and conditions using these compositions.USPTO title: Methods of making bempedoic acid and compositions of the same
Sources
- FDA Orange Book — patents listed against Nexletol (NDA filed 2020)
- Nexletol drug profile — full patent estate, indications, clinical trials, pricing
- Esperion Theraps Inc patent portfolio
- Patent cliff 2030 — 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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