FDA Orange Book · active-ingredient family
Omeprazole magnesium
Omeprazole magnesium is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRILOSEC · NDA 022056
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed release, for suspension, delayed release, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRILOSECRLD×2 | AZURITY | NDA 022056 | — | Mar 20, 2008 | |
| PRILOSEC OTCRLD | ASTRAZENECA | NDA 021229 | — | Jun 20, 2003 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMEPRAZOLE MAGNESIUM | MARKSANS PHARMA | ANDA 218829 | — | Aug 07, 2025 | |
| OMEPRAZOLE MAGNESIUM | AUROBINDO PHARMA LTD | ANDA 213201 | — | Apr 28, 2023 | |
| OMEPRAZOLE MAGNESIUM | DEXCEL | ANDA 216096 | — | May 24, 2022 | |
| OMEPRAZOLE MAGNESIUM | P AND L | ANDA 206582 | — | Jun 01, 2020 | |
| OMEPRAZOLE MAGNESIUM | HETERO LABS LTD III | ANDA 211732 | — | Mar 25, 2020 | |
| OMEPRAZOLE MAGNESIUM | SPIL | ANDA 210593 | — | Jul 20, 2018 | |
| OMEPRAZOLE MAGNESIUM | AUROBINDO PHARMA | ANDA 206877 | — | Jun 06, 2018 | |
| OMEPRAZOLE MAGNESIUM | PERRIGO R AND D | ANDA 204152 | — | Jul 30, 2015 | |
| OMEPRAZOLE MAGNESIUM | DR REDDYS LABS LTD | ANDA 078878 | — | Jun 05, 2009 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Omeprazole magnesium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
