FDA Orange Book · active-ingredient family
Esomeprazole magnesium; naproxen
Esomeprazole magnesium; naproxen is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VIMOVO · NDA 022511
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIMOVORLD×2 | HORIZON | NDA 022511 | — | Apr 30, 2010 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM×2 | SCIEGEN PHARMS | ANDA 217738 | AB | Oct 11, 2023 | |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM×2 | AJANTA PHARMA LTD | ANDA 213699 | AB | Oct 06, 2022 | |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM×2 | ACTAVIS LABS FL INC | ANDA 204470 | — | Aug 24, 2022 | |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM×2 | PHARMOBEDIENT | ANDA 204920 | — | Jul 20, 2021 | |
| NAPROXEN AND ESOMEPRAZOLE MAGNESIUM×2 | DR REDDYS | ANDA 204206 | AB | Feb 18, 2020 |
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 magnesium; naproxen — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
