Esomeprazole Magnesium

Treats heartburn and other symptoms associated GERD. Sold as Nexium, Nexium 24hr, Esomeprazole Magnesium. Every FDA application for this active ingredient: 6 branded and 50 generic.

As of Nov 15, 2026, FDA lists 56 applications for Esomeprazole Magnesium (sold as Nexium, Nexium 24hr, Esomeprazole Magnesium), first approved Feb 20, 2001, with 5 new uses approved and 0 published complete response letters.

First approved: Feb 20, 2001
Applications: 56
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $164M
First approved in the EU: Aug 26, 2013

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Esomeprazole Magnesium	Part D	$119M	-4%	768,560
Nexium	Part D	$45.1M	-24%	16,393

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ESOMEPRAZOLE DR 10 MG PACKET: $4.65 per unitGeneric · -33% in a year
ESOMEPRAZOLE DR 2.5 MG PACKET: $5.31 per unitGeneric · -26% in a year
ESOMEPRAZOLE DR 20 MG PACKET: $3.62 per unitGeneric · -40% in a year
ESOMEPRAZOLE DR 40 MG PACKET: $4.37 per unitGeneric · -34% in a year
ESOMEPRAZOLE DR 5 MG PACKET: $4.59 per unitGeneric · -36% in a year
NEXIUM DR 10 MG PACKET: $9.14 per unitBrand · 0% in a year
NEXIUM DR 2.5 MG PACKET: $9.16 per unitBrand · 0% in a year
NEXIUM DR 20 MG CAPSULE: $8.77 per unitBrand · 0% in a year
NEXIUM DR 20 MG PACKET: $9.14 per unitBrand · 0% in a year
NEXIUM DR 40 MG CAPSULE: $8.78 per unitBrand · 0% in a year
NEXIUM DR 40 MG PACKET: $9.12 per unitBrand · 0% in a year
NEXIUM DR 5 MG PACKET: $9.15 per unitBrand · 0% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of Eosinophilic EsophagitisAdare Pharmaceuticals US, L.P. · designated May 15, 2019

Approvals in the EU (EMA)

First approved in the EU 150 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Nexium Control, new substanceHaleon Ireland Dungarvan Limited · Aug 26, 2013

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

NexiumDrugs with a new additional pediatric dosage indicated for the prevention of recurrent reflux esophagitis and gastric or duodenal ulcer after dosing… · AstraZeneca K.K. · Jun 24, 2024
NexiumDrugs with a new additional pediatric dosage and in additional dosage forms indicated for the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer,… · AstraZeneca K.K. · Jan 19, 2018
NexiumDrugs with a new additional indication and a new dosage for the prevention of recurrence of gastric ulcer or duodenal ulcer in patients treated with low-… · AstraZeneca K.K. · Jun 22, 2012

Clinical Trials

3 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter PyloriHELICOBACTER PYLORI INFECTIONS · Xuanzhu Biopharmaceutical Co., Ltd.	Phase 3	Not yet recruiting	May 26, 2026
Esomeprazole Plus Sucralfate for Post-ESD Ulcer HealingEarly Gastric Cancer, Gastric Dysplasia · LanZhou University	Phase 4	Not yet recruiting	Dec 31, 2025
A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux EsophagitisReflux Esophagitis (RE) · Livzon Pharmaceutical Group Inc.	Phase 3	Recruiting	Feb 27, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 20, 2001	NexiumNDA 21153 · New active ingredient	Astrazeneca	41	Marketed
Oct 20, 2006	NexiumNDA 21957 · New dosage form	Astrazeneca	22	Marketed
Feb 27, 2008	NexiumNDA 22101 · New dosage form	Astrazeneca	20	Marketed
Mar 28, 2014	Nexium 24hrNDA 204655 · TYPE 8	Astrazeneca LP	10	Marketed
Jan 26, 2015	Esomeprazole MagnesiumANDA 78003	Cipla	0	Discontinued
Aug 3, 2015	Esomeprazole MagnesiumANDA 78936	Mylan	5	Marketed
Sep 21, 2015	Esomeprazole MagnesiumANDA 202784	Hetero Labs Ltd Iii	0	Discontinued
Sep 25, 2015	Esomeprazole MagnesiumANDA 78279	Dr Reddys	2	Marketed
Oct 19, 2015	Esomeprazole MagnesiumANDA 203636	Torrent	6	Discontinued
Nov 23, 2015	Nexium 24hrNDA 207920 · New dosage form	Astrazeneca LP	4	Marketed
Apr 21, 2016	Esomeprazole MagnesiumANDA 205606	Aurobindo Pharma Ltd	8	Marketed
Aug 18, 2017	Esomeprazole MagnesiumANDA 207193	Perrigo R And D	2	Marketed
Sep 1, 2017	Esomeprazole MagnesiumANDA 205563	Lannett Co Inc	0	Marketed
Oct 16, 2017	Esomeprazole MagnesiumANDA 209339	Aurobindo Pharma	3	Marketed
Oct 20, 2017	Esomeprazole MagnesiumANDA 208333	Alkem Labs Ltd	6	Marketed
Apr 30, 2018	Esomeprazole MagnesiumANDA 209735	Sun Pharm	5	Marketed
May 15, 2018	Esomeprazole MagnesiumANDA 207673	Dr Reddys	1	Marketed
May 18, 2018	Esomeprazole MagnesiumANDA 207265	Hec Pharm	1	Marketed
Mar 5, 2019	Esomeprazole MagnesiumANDA 209202	P And L	0	Discontinued
Apr 10, 2019	Esomeprazole MagnesiumANDA 209647	Amneal Pharms Ny	4	Discontinued
May 10, 2019	Esomeprazole MagnesiumANDA 209495	Glenmark Speclt	4	Discontinued
May 22, 2019	Esomeprazole MagnesiumANDA 206296	Zydus Pharms	4	Marketed
Jun 5, 2019	Esomeprazole MagnesiumANDA 209716	Amneal Pharms Ny	0	Discontinued
Oct 16, 2019	Esomeprazole MagnesiumANDA 212376	Pharmobedient	0	Discontinued
Mar 23, 2020	Esomeprazole MagnesiumANDA 211752	Cipla	4	Marketed
Mar 23, 2020	Esomeprazole MagnesiumANDA 211751	Cipla	4	Marketed
May 4, 2020	Esomeprazole MagnesiumANDA 212866	Sun Pharm	0	Marketed
May 14, 2020	Esomeprazole MagnesiumANDA 211571	Dr Reddys	0	Marketed
May 28, 2020	Esomeprazole MagnesiumANDA 208939	Hetero Labs Ltd Iii	0	Discontinued
Jun 2, 2020	Esomeprazole MagnesiumANDA 211977	Hetero Labs Ltd Iii	3	Marketed
Jun 2, 2020	Esomeprazole MagnesiumANDA 212507	Hetero Labs Ltd Iii	0	Marketed
Jun 25, 2020	Esomeprazole MagnesiumANDA 212088	Mylan	0	Discontinued
Sep 22, 2020	Esomeprazole MagnesiumANDA 213158	Cisen	0	Discontinued
Oct 2, 2020	Esomeprazole MagnesiumANDA 212949	Cspc Ouyi	0	Marketed
Oct 20, 2020	Esomeprazole MagnesiumNDA 214278 · New dosage form	Dexcel	2	Discontinued
Nov 18, 2020	Esomeprazole MagnesiumANDA 213859	Guangzhou Novaken	3	Marketed
Feb 26, 2021	Esomeprazole MagnesiumANDA 210559	Indchemie Health	2	Marketed
Mar 19, 2021	Esomeprazole MagnesiumANDA 213486	Graviti Pharms	3	Marketed
Mar 31, 2021	Esomeprazole MagnesiumANDA 90841	Ethypharm	0	Marketed
Jun 24, 2022	Esomeprazole MagnesiumANDA 216349	Graviti Pharms	1	Marketed
Mar 15, 2023	Esomeprazole MagnesiumANDA 216149	Guardian Drug	0	Marketed
Mar 28, 2023	Esomeprazole MagnesiumANDA 214920	Prinston	0	Marketed
Jun 7, 2023	Esomeprazole MagnesiumANDA 206055	Zydus Pharms	1	Marketed
Jul 12, 2023	Esomeprazole MagnesiumANDA 214473	Aurobindo Pharma Ltd	0	Marketed
Sep 29, 2023	Esomeprazole MagnesiumANDA 217264	Pharmazone	2	Marketed
Oct 18, 2023	Esomeprazole MagnesiumANDA 217427	Granules	0	Marketed
Dec 27, 2023	Esomeprazole MagnesiumANDA 217022	Zhejiang Yongtai	0	Marketed
Apr 30, 2024	Esomeprazole MagnesiumANDA 207198	Dr Reddys	0	Marketed
Jun 11, 2024	Esomeprazole MagnesiumANDA 218092	Glenmark Speclt	0	Marketed
Oct 23, 2024	Esomeprazole MagnesiumANDA 208511	Macleods Pharms	0	Discontinued
Jan 7, 2025	Esomeprazole MagnesiumANDA 217714	Cipla	0	Marketed
Mar 5, 2025	Esomeprazole MagnesiumANDA 212652	Torrent	0	Marketed
Mar 5, 2025	Esomeprazole MagnesiumANDA 212651	Torrent	0	Marketed
Apr 15, 2025	Esomeprazole MagnesiumANDA 218948	Aurobindo Pharma Ltd	0	Marketed
Apr 15, 2025	Esomeprazole MagnesiumANDA 219213	Aurobindo Pharma Ltd	0	Marketed
Sep 25, 2026	Esomeprazole MagnesiumANDA 218687	Novitium Pharma	0	Marketed

Show all 56

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA