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Nexium generic
About Nexium
Nexium (esomeprazole) — originally marketed by AstraZeneca. Class: Proton pump inhibitor (PPI). First approved 2001-02-20.
Approved generic versions (14)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
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.
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Related
- Nexium full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing