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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
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Esomeprazole strontium
Tradename
Company
Number
Date
Products
ESOMEPRAZOLE STRONTIUMBelcher PharmatechN-202342 DISCN2013-08-06
2 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
acid reducer powderANDA2025-03-03
basic care omeprazole and sodium bicarbonateANDA2021-07-22
equate omeprazole and sodium bicarbonateANDA2025-04-20
esomeprazole magnesiumANDA2025-06-11
esomeprazole strontiumNew Drug Application2022-11-18
exchange select omeprazoleNew Drug Application2024-12-19
good sense omeprazoleNew Drug Application2025-01-22
good sense omeprazole and sodium bicarbonateANDA2020-11-16
good sense omeprazole delayed releaseNew Drug Application2024-06-27
kirkland signature omeprazoleNew Drug Application2025-02-05
Show 12 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
561 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Peptic ulcerD010437—K271————1
Indications Without Phase
No data
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
$
€
£
â‚£
Nexium – AstraZeneca
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Vimovo – Horizon Therapeutics Public
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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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Number of purchases
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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 8,790 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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122,840 adverse events reported
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