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Drug ReportsEsomeprazole
Nexium, Nexium control(esomeprazole)
Esomeprazole, Esomeprazole Magnesium, Nexium (esomeprazole) is a small molecule pharmaceutical. Esomeprazole was first approved as Nexium on 2001-02-20. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, heartburn, and helicobacter infections amongst others in the USA. It has been approved in Europe to treat gastroesophageal reflux. The pharmaceutical is active against potassium-transporting ATPase alpha chain 1.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Esomeprazole, Esomeprazole magnesium, Nexium (discontinued: Esomeprazole, Esomeprazole magnesium, Nexium)
Combinations
Naproxen esomeprazole magnesium (discontinued: Naproxen esomeprazole magnesium, Vimovo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Esomeprazole sodium
Tradename
Company
Number
Date
Products
NEXIUM IVAstraZenecaN-021689 DISCN2005-03-31
2 products, RLD
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Esomeprazole magnesium
Tradename
Company
Number
Date
Products
NEXIUMAstraZenecaN-021153 RX2001-02-20
2 products, RLD, RS
NEXIUMAstraZenecaN-021957 RX2006-10-20
4 products, RLD, RS
NEXIUMAstraZenecaN-022101 RX2008-02-27
1 products, RLD
NEXIUM 24HRAstraZenecaN-204655 OTC2014-03-28
1 products, RLD, RS
NEXIUM 24HRAstraZenecaN-207920 OTC2015-11-23
1 products, RLD, RS
Show 1 discontinued
Esomeprazole magnesium
+
Naproxen
Tradename
Company
Number
Date
Products
VIMOVOHorizon Therapeutics PublicN-022511 DISCN2010-04-30
2 products, RLD
Hide discontinued
Esomeprazole strontium
Tradename
Company
Number
Date
Products
ESOMEPRAZOLE STRONTIUMBelcher PharmatechN-202342 DISCN2013-08-06
2 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
acid reducerANDA2026-03-25
acid reducer powderANDA2025-03-03
basic care esomeprazole magnesiumANDA2024-07-25
basic care omeprazole and sodium bicarbonateANDA2025-11-04
berkley and jensen heartburn treatmentANDA2026-01-19
careone esomeprazole magnesiumANDA2025-11-03
dg health esomeprazole magnesiumANDA2024-08-02
equaline esomeprazole magnesiumANDA2024-08-01
equate esomeprazole magnesiumANDA2026-03-19
equate omeprazole and sodium bicarbonateANDA2026-03-15
Show 39 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gastroesophageal refluxEFO_0003948D005764K21
helicobacter infectionsEFO_1000961D016481—
duodenal ulcerEFO_0004607D004381K26
zollinger-ellison syndrome—D015043E16.4
esophagitisHP_0100633D004941K20
heartburn—D006356R12
juvenile arthritisEFO_1002007D001171M08
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
headache—D006261R51
Show 9 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Esomeprazole Magnesium, Esomeprazole Magnesium, Dexcel
100764942036-12-08DP
108354882036-12-08DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BC: Proton pump inhibitors for peptic ulcer and gord
— A02BC05: Esomeprazole
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE52: Naproxen and esomeprazole
HCPCS
No data
Clinical
Clinical Trials
577 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastroesophageal refluxD005764EFO_0003948K21341725654
Peptic esophagitisD004942EFO_1001095—1177318
EsophagitisD004941HP_0100633K202365318
Stomach ulcerD013276—K251—91415
HeartburnD006356—R12——36110
Healthy volunteers/patients———7——2—9
Barrett esophagusD001471EFO_0000280K22.71—1316
DyspepsiaD004415EFO_0008533K30—132—6
Non-erosive reflux diseaseD000096663—————112
Abdominal painD015746EFO_0003766R10.9——11—2
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
UlcerD014456MPATH_579—2—11—417
Duodenal ulcerD004381EFO_0004607K261—5—410
Gastrointestinal diseasesD005767————6—28
Peptic ulcerD010437—K272—3—16
Digestive system diseasesD004066EFO_0000405K92.9——2—24
HemorrhageD006470MP_0001914R58——3——3
MetaplasiaD008679————1—12
Peptic ulcer hemorrhageD010438————2——2
GastrinomaD015408————1—12
Zollinger-ellison syndromeD015043—E16.4——1—12
Show 13 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J45—2———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD013810——3————3
PharmacokineticsD010599——2————2
Cardiovascular diseasesD002318EFO_0000319I981————1
Juvenile arthritisD001171EFO_1002007M081————1
ArthritisD001168EFO_0005856M05-M141————1
PancreatitisD010195EFO_0000278K851————1
Chronic pancreatitisD050500EFO_0000342K86.11————1
Exercise-induced asthmaD001250—J45.9901————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic diseasesD008659EFO_0000589E88.9————11
Calcium metabolism disordersD002128EFO_0005769E83.5————11
RecurrenceD012008——————11
Stomach neoplasmsD013274EFO_0003897C16————11
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3————11
Thrombocytopenic purpuraD011696——————11
PurpuraD011693HP_0000979D69.2————11
PneumoniaD011014EFO_0003106J18————11
ThrombocytopeniaD013921HP_0001873D69.6————11
SeizuresD012640—G40.4————11
Show 8 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEsomeprazole
INNesomeprazole
Description
(R)-omeprazole is a 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has R configuration at the sulfur atom. It is an enantiomer of an esomeprazole.
Classification
Small molecule
Drug classantiulcer agents (benzimidazole derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2[nH]c([S@@+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1
Identifiers
PDB—
CAS-ID119141-88-7
RxCUI—
ChEMBL IDCHEMBL1201320
ChEBI ID50275
PubChem CID9579578
DrugBankDB00736
UNII IDN3PA6559FT (ChemIDplus, GSRS)
Target
Agency Approved
ATP4A
ATP4A
Organism
Homo sapiens
Gene name
ATP4A
Gene synonyms
NCBI Gene ID
495
Protein name
potassium-transporting ATPase alpha chain 1
Protein synonyms
ATPase H+/K+ transporting alpha subunit, ATPase, H+/K+ exchanging, alpha polypeptide, ATPase, H+/K+ transporting, alpha polypeptide, epididymis secretory sperm binding protein, Gastric H(+)/K(+) ATPase subunit alpha, gastric H+/K+ ATPase alpha subunit, gastric H,K-ATPase catalytic subunit, gastric hydrogen-potassium ATPase, Proton pump
Uniprot ID
P20648
Mouse ortholog
Atp4a (11944)
potassium-transporting ATPase alpha chain 1 (Q9CV46)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Vimovo – Horizon Therapeutics Public
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Nexium – AstraZeneca
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Estimated US medical usage
Esomeprazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Esomeprazole
+
Naproxen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Naproxen and esomeprazole magnesium, Vimovo
Adverse Events
Top Adverse Reactions
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125,340 adverse events reported
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