Last reviewed · How we verify

Nexium generic

Complete generic competition for Nexium (esomeprazole): 14 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

14 approved generics Patents expired

About Nexium

Nexium (esomeprazole) — originally marketed by AstraZeneca. Class: Proton pump inhibitor (PPI). First approved 2001-02-20.

Approved generic versions (14)

GenericManufacturerPhaseFirst approvalCountry
ESOMEPRAZOLE MAGNESIUM marketed 2001-01-01
esomeprazole, amoxicillin, furazolidone,tetracycline Shandong University marketed
Esomeprazole (S14) National Taiwan University Hospital marketed
Esomeprazole (Nexium) Meridian Bioscience, Inc. marketed
esomeprazole (PPI) Thomas Jefferson University marketed
Esomeprazole Capsule Takeda marketed
Esomeprazole 40mg Hospital General de México Dr. Eduardo Liceaga marketed
Esomeprazole: Nexium® 20mg, Astra Zeneca Victoria Rollason marketed
esomeprazole 20 mg AstraZeneca marketed
esomeprazole 40 mg Far Eastern Memorial Hospital marketed
Esomeprazole (BQ10) National Taiwan University Hospital marketed
Esomeprazole (Intravenous) LanZhou University marketed
Esomeprazole Mg AstraZeneca marketed
Esomeprazole Na AstraZeneca marketed

Originator patent timeline

Active patents (0)

No active patents tracked.

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

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing