FDA Orange Book · active-ingredient family
Omeprazole
Omeprazole is approved as 3 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OMEPRAZOLE · NDA 209400
3
Brand (NDA)
21
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, delayed rel pellets, tablet, delayed release, tablet, orally disintegrating, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMEPRAZOLERLD | DEXCEL | NDA 209400 | — | Jul 05, 2017 | |
| OMEPRAZOLERLD | DEXCEL PHARMA | NDA 022032 | — | Dec 04, 2007 | |
| PRILOSECRLD×3 | ASTRAZENECA | NDA 019810 | — | Oct 05, 1995 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OMEPRAZOLE×3 | XIROMED | ANDA 212977 | AB | Dec 10, 2020 | |
| OMEPRAZOLE×2 | HETERO LABS LTD III | ANDA 204012 | AB | Sep 26, 2019 | |
| OMEPRAZOLE | APOTEX | ANDA 210070 | — | Feb 11, 2019 | |
| OMEPRAZOLE | DR REDDYS | ANDA 207740 | — | Nov 05, 2018 | |
| OMEPRAZOLE | SUN PHARM | ANDA 207891 | — | Oct 12, 2018 | |
| OMEPRAZOLE×3 | PHARMOBEDIENT | ANDA 205070 | — | Jun 29, 2018 | |
| OMEPRAZOLE×3 | BRECKENRIDGE | ANDA 203481 | AB | Jul 03, 2017 | |
| OMEPRAZOLE×2 | TEVA PHARMS USA | ANDA 204661 | AB | Jun 13, 2017 | |
| OMEPRAZOLE | LUPIN | ANDA 202384 | — | Aug 25, 2015 | |
| OMEPRAZOLE×3 | AUROBINDO PHARMA | ANDA 203270 | AB | Aug 19, 2015 | |
| OMEPRAZOLE×3 | GLENMARK PHARMS LTD | ANDA 091672 | AB | Oct 31, 2014 | |
| OMEPRAZOLE×3 | ZYDUS PHARMS USA INC | ANDA 091352 | AB | Nov 19, 2012 | |
| OMEPRAZOLE×3 | DR REDDYS LABS LTD | ANDA 078490 | AB | Mar 16, 2009 | |
| OMEPRAZOLE | SANDOZ | ANDA 076515 | AB | Jan 21, 2009 | |
| OMEPRAZOLE×3 | ACTAVIS LABS FL INC | ANDA 075347 | AB | May 30, 2008 | |
| OMEPRAZOLE×3 | APOTEX | ANDA 076048 | AB | Oct 22, 2007 | |
| OMEPRAZOLE×3 | DR REDDYS LABS LTD | ANDA 075576 | AB | Oct 22, 2007 | |
| OMEPRAZOLE×3 | IMPAX LABS | ANDA 075785 | AB | Oct 22, 2007 | |
| OMEPRAZOLE×3 | STRIDES PHARMA | ANDA 075876 | — | May 29, 2003 | |
| OMEPRAZOLE×2 | SANDOZ | ANDA 075757 | AB | Jan 28, 2003 | |
| OMEPRAZOLE×3 | LANNETT CO INC | ANDA 075410 | AB | Nov 01, 2002 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12599565 | Jan 31, 2030 | in 3 yr 8 mo | Product |
| 10835488 | Dec 08, 2036 | in 10 yr 8 mo | Product |
| 10076494 | Dec 08, 2036 | in 10 yr 8 mo | Product |
Omeprazole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
