Vasotec generics — when can they launch?
Vasotec (ENALAPRIL MALEATE) · Azurity · 13 active US patents · 0 expired
Where Vasotec sits in the generic timeline
Mid-term cliff: earliest active US patent for Vasotec expires in 2032 (~6 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.
- Formulation — 9 patents
- Method of Use — 4 patents
FDA U-codes carved out by Vasotec 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-3 | Treatment of inflammatory conditions |
U-71 | (no description) |
Sample patent estate
Showing 6 of 13 active US patents. View full estate on the Vasotec drug page →
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This patent protects stable enalapril powder compositions for oral liquid formulation and methods of using them to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril compositions
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This patent protects stable enalapril powder compositions for oral liquid formulation and methods of using them to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril compositions
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This patent protects stable enalapril powder compositions for oral liquid formulation used in the treatment of hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril compositions
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This patent protects stable enalapril powder compositions for oral liquid formulation used in the treatment of hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril compositions
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This patent protects stable enalapril oral liquid formulations and methods of using them to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril formulations
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This patent protects stable enalapril oral liquid formulations and methods of using them to treat hypertension, heart failure, and asymptomatic left ventricular dysfunction.USPTO title: Enalapril formulations
Sources
- FDA Orange Book — patents listed against Vasotec (NDA filed 1985)
- Vasotec drug profile — full patent estate, indications, clinical trials, pricing
- Azurity patent portfolio
- Patent cliff 2032 — 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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