Zestril generics — when can they launch?
Zestril (lisinopril) · Generic (originally Merck/AstraZeneca) · 12 active US patents · 0 expired
Where Zestril sits in the generic timeline
Long-dated protection: earliest active US patent for Zestril extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 8 patents
- Method of Use — 4 patents
FDA U-codes carved out by Zestril 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-1723 | (no description) |
U-3 | Treatment of inflammatory conditions |
U-8 | Treatment of infectious diseases |
U-1864 | (no description) |
Sample patent estate
Showing 6 of 12 active US patents. View full estate on the Zestril drug page →
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
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This patent protects stable lisinopril oral liquid formulations for treating hypertension, heart failure, and acute myocardial infarction.USPTO title: Lisinopril formulations
Sources
- FDA Orange Book — patents listed against Zestril (NDA filed 1987)
- Zestril drug profile — full patent estate, indications, clinical trials, pricing
- Generic (originally Merck/AstraZeneca) patent portfolio
- Patent cliff 2035 — 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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