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Prilosec generic
About Prilosec
Prilosec (omeprazole) — originally marketed by AstraZeneca (originally Astra AB). Class: Proton pump inhibitor (PPI). First approved 1989-09-14.
Approved generic versions (11)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| omeprazole, 20mg twice daily | Tel-Aviv Sourasky Medical Center | marketed | ||
| Omeprazole, amoxicillin, clarithromycin | Forest Laboratories | marketed | ||
| Omeprazole, Lansoprazole, Esomeprazole, Rantidine | Temple University | marketed | ||
| omeprazole+domperidone SR | Belarusian Medical Academy of Post-Graduate Education | marketed | ||
| Omeprazole Low dose | Damascus Hospital | marketed | ||
| omeprazole/sodium bicarbonate | Food and Drug Administration (FDA) | marketed | ||
| omeprazole sodium IV | The Catholic University of Korea | marketed | ||
| Omeprazole, Amoxicillin and Clarithromycin | Al-Azhar University | marketed | ||
| Omeprazole and domperidone | Mansoura University Children Hospital | marketed | ||
| omeprazole plus amoxicillin | National Taiwan University Hospital | marketed | ||
| Omeprazole, Amoxicillin, Metronidazole and Clarithromycin | Al-Azhar University | marketed |
Originator patent timeline
Active patents (2)
- —
10835488· Formulation · US - —
10076494· 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.