Generic competition · all medicines · read 12 November 2026
Is there a generic of Omeprazole, and who makes it?
Omeprazole appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 10.9 and 13.1 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Omeprazole appears in 3 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 14 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 10.9 and 13.1 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Capsule, Delayed Rel Pellets, Oral
Four or more generic makers listed
Every brand product here is listed as discontinued. 13 generic makers with 39 generic products listed as marketed; the first generic approval is dated 1 November 2002.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Lannett Co Inc | 1 November 2002 | 3 |
| Sandoz Inc | 28 January 2003 | 3 |
| Apotex Inc | 22 October 2007 | 3 |
| Dr Reddys Laboratories Ltd | 22 October 2007 | 6 |
| Impax Laboratories Inc | 22 October 2007 | 3 |
| Actavis Laboratories Fl Inc | 30 May 2008 | 3 |
| Zydus Pharmaceuticals Usa Inc | 19 November 2012 | 3 |
| Glenmark Pharmaceuticals Ltd | 31 October 2014 | 3 |
| Aurobindo Pharma Ltd | 19 August 2015 | 3 |
| Teva Pharmaceuticals Usa | 13 June 2017 | 1 |
| Breckenridge Pharmaceutical Inc | 3 July 2017 | 3 |
| Hetero Labs Ltd Unit Iii | 26 September 2019 | 2 |
1 more makers are listed in the data.
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Delayed Release, Oral
One to three generic makers listed
Brand listed as marketed: Omeprazole. 2 generic makers with 2 generic products listed as marketed; the first generic approval is dated 12 October 2018.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Sun Pharmaceutical Industries Ltd | 12 October 2018 | 1 |
| Dr Reddys Laboratories Ltd | 5 November 2018 | 1 |
Patents and exclusivities still listed
- 31 January 2030Patent 12599565 drug product
Tablet, Orally Disintegrating, Delayed Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Omeprazole. No generic is listed as marketed.
Patents and exclusivities still listed
- 8 December 2036Patent 10835488 drug product
- 8 December 2036Patent 10076494 drug product
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.