Last reviewed · How we verify

Zestril generic

Complete generic competition for Zestril (lisinopril): 1 approved generics across manufacturers, 0 filed under FDA review. 12 active patents remain. Sourced from FDA Orange Book + USPTO.

1 approved generics 12 active patents

About Zestril

Zestril (lisinopril) — originally marketed by Generic (originally Merck/AstraZeneca). Class: Thiazide Diuretic [EPC]. First approved 1987-12-29.

Approved generic versions (1)

GenericManufacturerPhaseFirst approvalCountry
Lisinopril Tablets University of Rochester marketed

Originator patent timeline

Active patents (12)

Expired patents (0)

No expired patents tracked.

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.

Subscribe to generic updates

Related