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Prilosec generic

Complete generic competition for Prilosec (omeprazole): 11 approved generics across manufacturers, 0 filed under FDA review. 2 active patents remain. Sourced from FDA Orange Book + USPTO.

11 approved generics 2 active patents

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)

GenericManufacturerPhaseFirst approvalCountry
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)

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.

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