Omeprazole
Konvomep, 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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Trade Name
FDA
EMA
Prilosec (generic drugs available since 2002-11-01, discontinued: Prilosec)
CombinationsKonvomep, Talicia, Zegerid (generic drugs available since 2002-11-01, discontinued: Yosprala, Zegerid)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amoxicillin
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Clarithromycin
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Omeprazole
Tradename | Company | Number | Date | Products |
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OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN | Cumberland Pharmaceuticals | N-050824 DISCN | 2011-02-08 | 1 products, RLD |
Hide discontinued
Amoxicillin
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Omeprazole magnesium
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Rifabutin
Tradename | Company | Number | Date | Products |
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TALICIA | RedHill Biopharma | N-213004 RX | 2019-11-01 | 1 products, RLD, RS |
Aspirin
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Omeprazole
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
YOSPRALA | Genus Lifesciences | N-205103 DISCN | 2016-09-14 | 2 products, RLD |
Hide discontinued
Magnesium hydroxide
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Omeprazole
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Sodium bicarbonate
Omeprazole
Omeprazole
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Sodium bicarbonate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
KONVOMEP | Azurity | N-213593 RX | 2022-08-30 | 1 products, RLD, RS |
ZEGERID OTC | Riley Consumer Care Holdings | N-022281 OTC | 2009-12-01 | 1 products, RLD, RS |
ZEGERID OTC | Riley Consumer Care Holdings | N-022283 OTC | 2013-06-17 | 1 products, RLD, RS |
ZEGERID | Salix Pharmaceuticals | N-021636 RX | 2004-06-15 | 2 products, RLD |
ZEGERID | Salix Pharmaceuticals | N-021849 RX | 2006-02-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
konvomep | New Drug Application | 2022-08-30 |
omeprazole | New Drug Application | 2023-06-06 |
prilosec otc | New Drug Application | 2023-05-03 |
talicia | New Drug Application | 2021-10-05 |
yosprala | New Drug Application | 2021-08-31 |
zegerid otc | ANDA | 2022-12-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
duodenal ulcer | EFO_0004607 | D004381 | K26 |
esophagitis | HP_0100633 | D004941 | K20 |
gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
heartburn | — | D006356 | R12 |
helicobacter infections | EFO_1000961 | D016481 | — |
stomach ulcer | — | D013276 | K25 |
zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Omeprazole / Sodium Bicarbonate, Konvomep, Azurity | |||
10751333 | 2039-07-16 | DP | |
11103492 | 2039-07-16 | DP | |
11633478 | 2039-07-16 | DP | |
Omeprazole, Omeprazole, Dexcel | |||
10076494 | 2036-12-08 | DP | |
10835488 | 2036-12-08 | DP | |
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill | |||
9050263 | 2034-02-12 | DP | U-2660 |
9498445 | 2034-02-12 | DP | U-2660 |
9603806 | 2034-02-12 | DP | U-2660 |
10238606 | 2034-02-12 | DP | |
11135172 | 2034-02-12 | DP | U-2660 |
Aspirin / Omeprazole, Yosprala, Genus Lifesciences | |||
9539214 | 2033-03-13 | U-1902 | |
9987231 | 2033-01-02 | U-2324 | |
6926907 | 2023-02-28 | DP | U-1902 |
8206741 | 2023-02-28 | DP | U-1902 |
Omeprazole, Omeprazole, Dexcel Pharma | |||
9023391 | 2025-08-16 | DP |
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
360 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 84 | — | — | 2 | 3 | 89 | ||
Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 6 | 4 | 5 | 8 | 7 | 29 |
Infections | D007239 | EFO_0000544 | 1 | 1 | 3 | 7 | 3 | 14 | |
Drug interactions | D004347 | 6 | — | — | 1 | 1 | 8 | ||
Peptic ulcer | D010437 | HP_0004398 | K27 | 1 | — | 1 | 5 | 1 | 8 |
Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 5 | — | 1 | 1 | — | 7 |
Coronary artery disease | D003324 | I25.1 | — | — | 1 | 4 | 1 | 6 | |
Peptic ulcer hemorrhage | D010438 | — | 1 | 2 | 2 | 1 | 6 | ||
Dyspepsia | D004415 | EFO_0008533 | K30 | 1 | 1 | 1 | 1 | 1 | 5 |
Laryngopharyngeal reflux | D057045 | EFO_1001355 | — | — | — | 5 | — | 5 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Gastritis | D005756 | EFO_0000217 | K29.7 | — | 2 | 2 | — | 1 | 4 |
Peptic esophagitis | D004942 | EFO_1001095 | 1 | — | 2 | — | — | 3 | |
Human experimentation | D006805 | — | — | 3 | — | — | 3 | ||
Helicobacter infections | D016481 | EFO_1000961 | — | — | 2 | — | — | 2 | |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 2 | — | — | 2 |
Exocrine pancreatic insufficiency | D010188 | K86.81 | — | 1 | 1 | — | — | 2 | |
Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
Percutaneous coronary intervention | D062645 | — | — | 1 | — | — | 1 | ||
Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | 1 | |
Neurocysticercosis | D020019 | — | — | 1 | — | — | 1 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 14 | 1 | — | — | — | 15 | |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 2 | 1 | — | — | — | 3 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | — | — | — | 3 |
Prostatic neoplasms | D011471 | C61 | 1 | 1 | — | — | — | 2 | |
Castration-resistant prostatic neoplasms | D064129 | 1 | 1 | — | — | — | 2 | ||
Lymphoma | D008223 | C85.9 | — | 2 | — | — | — | 2 | |
Squamous cell carcinoma of head and neck | D000077195 | — | 2 | — | — | — | 2 | ||
Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | — | — | — | 1 |
Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | — | 1 | |
Fatty liver | D005234 | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv infections | D015658 | EFO_0000764 | B20 | 5 | — | — | — | — | 5 |
Pharmacokinetics | D010599 | 4 | — | — | — | — | 4 | ||
Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | — | — | — | — | 3 |
Psoriasis | D011565 | EFO_0000676 | L40 | 2 | — | — | — | — | 2 |
Atopic dermatitis | D003876 | EFO_0000274 | L20 | 2 | — | — | — | — | 2 |
Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 2 | — | — | — | — | 2 |
Clostridium infections | D003015 | EFO_1000874 | A05.2 | 1 | — | — | — | 1 | 2 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 2 | — | — | — | — | 2 |
Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
Platelet aggregation | D010974 | GO_0070527 | 1 | — | — | — | — | 1 |
Show 24 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 5 | 5 |
Covid-19 | D000086382 | U07.1 | — | — | — | — | 1 | 1 | |
Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
B-cell lymphoma marginal zone | D018442 | C88.4 | — | — | — | — | 1 | 1 | |
Bile reflux | D001655 | EFO_1000838 | — | — | — | — | 1 | 1 | |
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 1 | 1 |
Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | OMEPRAZOLE |
INN | omeprazole |
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 class | antiulcer agents (benzimidazole derivatives) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | COc1ccc2[nH]c([S+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1 |
Identifiers
PDB | — |
CAS-ID | 73590-58-6 |
RxCUI | 7646 |
ChEMBL ID | CHEMBL1503 |
ChEBI ID | 77260 |
PubChem CID | 4594 |
DrugBank | DB00338 |
UNII ID | KG60484QX9 (ChemIDplus, GSRS) |
Target
Agency Approved
ATP4A
ATP4A
Organism
Homo sapiens
Gene name
ATP4A
Gene synonyms
NCBI Gene ID
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
Mouse ortholog
Atp4a (11944)
potassium-transporting ATPase alpha chain 1 (Q9CV46)
Variants
Clinical Variant
No data
Financial
Prilosec - AstraZeneca
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Trends
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Safety
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Adverse Events
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14,122 adverse events reported
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