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Drug ReportsOmeprazole
Omeprazole
Konvomep, Omeclamox-pak, Omeprazole, Prilosec, Talicia, Yosprala, Zegerid (omeprazole) is a small molecule pharmaceutical. Omeprazole was first approved as Prilosec on 1989-09-14. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, heartburn, and helicobacter infections amongst others in the USA. The pharmaceutical is active against potassium-transporting ATPase alpha chain 1. In addition, it is known to target chloride channel protein 2.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Omeprazole, Omeprazole magnesium, Prilosec (discontinued: Omeprazole, Omeprazole magnesium, Prilosec)
Combinations
Konvomep, Omeprazole bicarbonate, Talicia, Zegerid (discontinued: Magnesium hydroxide omeprazole bicarbonate, Omeclamox-pak, Omeprazole bicarbonate, Yosprala, Zegerid)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Omeprazole
+
Sodium bicarbonate
Tradename
Company
Number
Date
Products
KONVOMEPAzurityN-213593 RX2022-08-30
1 products, RLD, RS
ZEGERID OTCRiley Consumer Care HoldingsN-022281 OTC2009-12-01
1 products, RLD, RS
ZEGERID OTCRiley Consumer Care HoldingsN-022283 OTC2013-06-17
1 products, RLD, RS
Show 2 discontinued
Omeprazole
Tradename
Company
Number
Date
Products
OMEPRAZOLEDexcel PharmaN-209400 OTC2017-07-05
1 products, RLD, RS
OMEPRAZOLEDexcel PharmaN-022032 OTC2007-12-04
1 products, RLD, RS
Show 1 discontinued
Aspirin
+
Omeprazole
Tradename
Company
Number
Date
Products
YOSPRALAGenus LifesciencesN-205103 DISCN2016-09-14
2 products, RLD
Hide discontinued
Amoxicillin
+
Clarithromycin
+
Omeprazole
Tradename
Company
Number
Date
Products
OMECLAMOX-PAKCumberland PharmaceuticalsN-050824 DISCN2011-02-08
1 products, RLD
Hide discontinued
Magnesium hydroxide
+
Omeprazole
+
Sodium bicarbonate
Tradename
Company
Number
Date
Products
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATESantarusN-022456 DISCN2009-12-04
2 products
ZEGERIDSantarusN-021850 DISCN2006-03-24
2 products
Hide discontinued
Amoxicillin
+
Omeprazole magnesium
+
Rifabutin
Tradename
Company
Number
Date
Products
TALICIARedHill BiopharmaN-213004 RX2019-11-01
1 products, RLD, RS
Omeprazole magnesium
Tradename
Company
Number
Date
Products
PRILOSEC OTCAstraZenecaN-021229 OTC2003-06-20
1 products, RLD, RS
PRILOSECCovis PharmaN-022056 RX2008-03-20
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
24 hr omeprazoleNew Drug Application2022-06-01
acid reducerANDA2024-08-15
acid reducer powderANDA2024-12-01
amazon basic care omeprazoleANDA2024-05-10
aspirin and omeprazole delayed-release tabNew Drug Application2019-11-20
basic care omeprazoleNew Drug Application2024-12-19
basic care omeprazole and sodium bicarbonateANDA2021-07-22
berkley and jensen omeprazoleNew Drug Application2023-06-28
care one omeprazoleNew Drug Application2019-05-20
careone omeprazoleNew Drug Application2022-06-07
Show 52 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gastroesophageal refluxEFO_0003948D005764K21
helicobacter infectionsEFO_1000961D016481—
stomach ulcer—D013276K25
duodenal ulcerEFO_0004607D004381K26
zollinger-ellison syndrome—D015043E16.4
esophagitisHP_0100633D004941K20
heartburn—D006356R12
rheumatoid arthritisEFO_0000685D001172M06.9
painEFO_0003843D010146R52
feverHP_0001945D005334R50.9
Show 27 more
Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL
2027-11-01GAIN
2022-11-01NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
118780112042-05-27U-3816
90502632034-02-12DPU-2660
94984452034-02-12DPU-2660
96038062034-02-12DPU-2660
102386062034-02-12DP
111351722034-02-12DPU-2660
Omeprazole / Sodium Bicarbonate, Konvomep, Azurity
117716862040-03-01U-623
107513332039-07-16DP
111034922039-07-16DP
116334782039-07-16DP
Omeprazole, Omeprazole, Dexcel
100764942036-12-08DP
108354882036-12-08DP
Aspirin / Omeprazole, Yosprala, Genus Lifesciences
95392142033-03-13U-1902
99872312033-01-02U-2324
Omeprazole, Omeprazole, Dexcel Pharma
90233912025-08-16DP
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
— A02BC01: Omeprazole
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD01: Omeprazole, amoxicillin and metronidazole
— A02BD05: Omeprazole, amoxicillin and clarithromycin
— A02BD16: Omeprazole, amoxicillin and rifabutin
HCPCS
No data
Clinical
Clinical Trials
782 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Celiac diseaseD002446EFO_0001060K90.0———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOmeprazole
INNomeprazole
Description
6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole is a member of benzimidazoles and a sulfoxide.
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-ID73590-58-6
RxCUI—
ChEMBL IDCHEMBL1503
ChEBI ID77260
PubChem CID4594
DrugBankDB00338
UNII IDKG60484QX9 (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
CLCN2
CLCN2
Organism
Homo sapiens
Gene name
CLCN2
Gene synonyms
NCBI Gene ID
1181
Protein name
chloride channel protein 2
Protein synonyms
chloride channel 2, chloride channel, voltage-sensitive 2
Uniprot ID
P51788
Mouse ortholog
Clcn2 (12724)
chloride channel protein 2 (Q9WUJ9)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Prilosec – AstraZeneca
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Estimated US medical usage
Omeprazole
+
Amoxicillin
+
Clarithromycin
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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Omeprazole
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 26,598 documents
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Safety
Black-box Warning
Black-box warning for: Previdolrx analgesic pak
Adverse Events
Top Adverse Reactions
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150,482 adverse events reported
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