Last reviewed · How we verify
Zestril generic
About Zestril
Zestril (lisinopril) — originally marketed by Generic (originally Merck/AstraZeneca). Class: Thiazide Diuretic [EPC]. First approved 1987-12-29.
Approved generic versions (1)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Lisinopril Tablets | University of Rochester | marketed |
Originator patent timeline
Active patents (12)
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9616096· Method of Use · US - —
10039800· Method of Use · US - —
10406199· Method of Use · US - —
12433931· Method of Use · US - —
10265370· Formulation · US - —
9463183· Formulation · US - —
11179434· Formulation · US - —
9814751· Formulation · US - —
10940177· Formulation · US - —
11771733· Formulation · US - —
12186360· Formulation · US - —
12128083· Formulation · US
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.