FDA Orange Book · active-ingredient family
Esomeprazole sodium
Esomeprazole sodium is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEXIUM IV · NDA 021689
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEXIUM IVRLD×2 | ASTRAZENECA | NDA 021689 | — | Mar 31, 2005 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ESOMEPRAZOLE SODIUM | EPIC PHARMA LLC | ANDA 214046 | AP | Jan 08, 2025 | |
| ESOMEPRAZOLE SODIUM | SLATE RUN PHARMA | ANDA 215732 | AP | Feb 10, 2022 | |
| ESOMEPRAZOLE SODIUM×2 | GLAND | ANDA 203349 | — | Apr 01, 2020 | |
| ESOMEPRAZOLE SODIUM×2 | PHARMOBEDIENT | ANDA 202686 | — | May 17, 2017 | |
| ESOMEPRAZOLE SODIUM | DEVA HOLDING AS | ANDA 207181 | AP | Mar 06, 2017 | |
| ESOMEPRAZOLE SODIUM×2 | EUGIA PHARMA | ANDA 204657 | — | Aug 10, 2016 | |
| ESOMEPRAZOLE SODIUM | ACCORD HLTHCARE | ANDA 205379 | — | Sep 25, 2015 | |
| ESOMEPRAZOLE SODIUM×2 | SUN PHARM | ANDA 200882 | — | Mar 18, 2013 |
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.
Esomeprazole sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
